Recall Health FAQs
Are all Recall Health users authenticated?
Product recalls and withdrawals have the potential for dramatic implications on Australian businesses of any size. As a result, GS1 Australia is committed to providing Recall Health users with a secure and standardised method of authentication for all users.
Every Primary Contact is authenticated and each subsequent user assigned by the Primary Contact is required to accept the Recall Health Terms and Conditions for Australian users.
Can customers who are not on Recall Health be emailed a recall notification?
Yes. You can include non-subscribed recipients in the notification. They will receive an email with basic details of the notification and a link to the recall letter.
Can Recall Health be used for notifications other than recalls, i.e. a shortage of a particular product?
Currently, no. The system has been designed to deliver the functions of the Uniform Recall Protocol as defined by the TGA.
However, we are looking to prepare a joint proposal to have the TGA review their protocol, as product shortages could also be a safety issue. If they do, we will build it into the system.
Does GS1 Australia authenticate Primary Contacts on Recall Health?
It is very important that only authorised Primary Contacts have access to Recall Health - not only for your organisation, but to also maintain security and trust of all Recall Health users.
GS1 Australia undertakes a comprehensive verification process of the nominated Primary Contact before granting access to Recall Health. Confirmation from a Person of Authority (POA), an appropriate signing officer, such as Human Resources or an executive level contact is required. Once confirmation is received by the signing officer, GS1 Australia will grant the organisation access to Recall Health.
How can my organisation register for Recall Health?
You can register online.
Note: You'll need to assign a Primary Contact for your company's use of Recall Health, to ensure that only authorised notifications are issued. It's their responsibility to assign users based on their role when a recall is issued (such as Initiator, Receiver or Approver). Unless these roles are assigned, you can't use Recall Health to issue a recall or withdrawal notification.
How do I change my organisation’s Primary Contact on Recall Health?
Any request to change your Primary Contact must be approved by the Recall Administrator. This helps maintain the security of Recall Health.
To make the change, the current Primary Contact must create a new user or nominate an existing user as the new Primary Contact. Steps include:
- The current Primary Contact must email the GS1 Australia Administrator.
- GS1 Australia will review the information and verify the newly nominated Primary Contact.
- The GS1 Australia Administrator will remove the Primary Contact role from the current user and assign it to the newly nominated Primary Contact.
How do I change my password on Recall Health?
From the Recall Health login screen, select Forgot Password and follow the on-screen prompts. We'll send you a temporary password, which you can use to login and then change your password.
Note: Passwords must be at least eight characters in length and contain at least one letter, one digit and one symbol.
How do I correct or change my contact information on Recall Health?
Only the Primary Contact within your organisation is able to change contact information, which is done via the Manage My Account screen. To edit contact information, select Edit User.
How do I log out of Recall Health?
To log out, click on the Log Out link located on the top right of the application.
How do I modify a recall notification that my organisation has already issued?
Product recall notifications can be updated (or extended) by issuing an updated recall notification. All changes will be highlighted in red to notify recipients of the modifications.
How do I provide feedback on Recall Health?
Your feedback is important to us and you can provide it in one of two ways:
- Login to Recall Health and select Contact Us in the footer menu. You can provide feedback on this form
- Send us an email
How does Recall Health handle hazard notifications to surgeons?
When a hospital is sent a recall notification regarding a product that has already gone into a patient, e.g. orthopaedics, a hazard notification is sent to the surgeon who performed the procedure. Hazard notifications are also used to update surgeons about surgical techniques.
Recall Health can also send hazard notifications to surgeons who are not subscribed. The hospital receiving the recall notification can simply add the relevant surgeons as non-subscribed recipients, and the surgeons will be notified.
How does Recall Health handle radiopharmaceutical recall communications?
As specified in the Uniform Recall Procedure for Therapeutic Goods, a special procedure is used for the initiation of recalls for short-lived radiopharmaceuticals, some of which are distributed before all quality control tests are completed.
If such a product is shown not to comply with relevant specifications or if, for some other reason, doubt exists as to the product's quality, safety or efficacy, the head of the distributing organisation's radioactive products section or a nominated deputy must take immediate action to prevent its use by informing users by telephone or facsimile and seeking acknowledgment. The Australian Recall Coordinator should also be advised immediately.
Then, Recall Health can be used to formally submit the recall information to the TGA. After TGA review, it can be forwarded to affected customers.
How long is a Recall Health session?
Your session will last as long as it takes to fill out the various forms. However, Recall Health will automatically terminate a session after 60 minutes of inactivity.
I forgot my Recall Health password. What do I do?
You can reset your password using the Forgot Password link on the Recall Health login page. Or, speak to the Primary Contact, who can help you reset your password.
Note: Your account will be disabled after three unsuccessful login attempts.
I need to issue a recall immediately, but my organisation is not yet registered with Recall Health. Can I issue a recall as soon as I register?
Once you submit your registration, it should be processed by the following business day. Then, you'll need to complete some set-up activities (create users and templates).
When these activities are completed, you can issue a recall or withdraw notice.
Note: It's also important to ensure that you update your recall management plans to incorporate the use of Recall Health.
Is Recall Health only for products that are TGA listed, or can it be used by food services companies?
Recall Health is only for therapeutic products that are regulated by the TGA.
For food products regulated by FSANZ and ACCC you should use Recall.
Note: Health authorities may also use Recall to receive recall and withdrawal notifications from food service providers.
Is Recall Health secure?
Yes. Recall Health uses the Secure Sockets Layer (SSL) security protocol, which runs in the background and is invoked when required.
My organisation doesn’t anticipate recalling any products. Why should I register for Recall Health?
No organisation plans on recalling a product. However, despite best due diligence, product recalls sometimes occur.
With Recall Health, in the event of a recall, you can instantly reassure end users that you have the processes in place to ensure their safety. It's a powerful tool to maintain your brand's reputation.
My product does not have a GTIN. Can Recall Health still be used to send the notification?
Yes. You can include a product that does not have a GTIN on a notification, as long as it has another unique identifier e.g. ARTG ID or Internal Product ID.
The Recall Health form is requesting a GTIN and/or GLN to identify my products. What are these?
A Global Trade Item Number (GTIN) is a unique number assigned to every item, product or service that may be priced, ordered or invoiced at any point in any supply chain. GTINs are used to retrieve pre-defined information about the item it represents
A Global Location Number (GLN) is the GS1 ID key for locations. GLNs can be used to identify physical locations and legal entities, and help improve the efficiency of communication within the supply chain.
What are Company Types on Recall Health?
You're asked to select a Company Type during the registration process. These include:
Initiator: A Recall Initiator is typically a manufacturer or supplier. The Initiator is responsible for providing accurate, clear and timely information regarding a recalled product to a Recall Receiver.
Receiver: A Recall Receiver is typically a retailer, wholesaler or distributor. The Receiver is responsible for taking action on the product recall information sent by the Recall Initiator in a timely manner.
Both: A company that is defined as Both is typically a manufacturer or distributor that may need to perform either the Recall Initiator or Receiver roles, depending on their relationship with the recalled product.
What are the features of Recall Health?
Recall Health has been built for ease of use - to reduce errors, reduce costs and get important information out faster.
- A single, standardised process for communicating recall and withdrawal information
- Clear tracking and reporting, so you know whether recall and withdrawal information was received by supply chain partners
- Ability to identify original distribution area and products still in distribution
- Secure online web access anywhere, anytime
- Cross-border interoperability
- Improved business processes for responding to recalls and withdrawals
- Ability to embed product images, additional product information and instructions into notifications
- A regularly updated database of product recall coordinators
- Detailed audit trail of events, which we use to continuously enhance the process
What Internet browsers support Recall Health?
You can use these browsers:
- Internet Explorer 7 and above
- Mozilla Firefox 2 and above
- Safari 5 and above
- Google Chrome 14 and above
- Opera 9 and above
What is a Primary Contact on Recall Health?
The Primary Contact is the user that registers for Recall Health on your company's behalf. They are responsible for choosing Company Type, confirming company information and assigning user access and roles.
Depending on Company Type, Primary Contacts also have a user role automatically assigned to them at registration:
||Primary Contact User Role
Given their central role, the Primary Contact undergoes a comprehensive verification and authentication process during registration.
What is Recall Health?
Recall Health is an electronic product recall management system that was developed in consultation with industry. It enables suppliers to quickly and accurately send recall or withdrawal notifications in accordance with TGA requirements for therapeutic goods.
What is the Recall Health refund policy?
Subscribers are not eligible for a refund once they have subscribed to Recall Health.
Who can use Recall Health?
Recall Health is designed to meet the needs of the entire healthcare supply chain. Any retailer, manufacturer or distributor that may need to issue a product recall or withdrawal notification to trading partners can use it.
It is not limited to manufacturer-to-retailer product recalls. Other examples of its application include:
- Producers issuing recall notifications to distributors
- Distributors issuing recall notifications to manufacturers
- State Health Departments and agencies on-forwarding notifications to hospitals, clinics and retailers
Why should I use Recall Health?
Use Recall Health to:
- Prevent recalled or withdrawn products from reaching the end user
- Connect with your trading partners with faster, simpler communication
- Boost consumer confidence
- Protect your brand