| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00787-1 |
| Product Name/Description |
Strongyloides ratti IgG ELISA, 96 well. An in vitro diagnostic medical device (IVD).
Product Code: 9450
Batch number: 2419S
Expiry Date: 28/01/2026
ARTG 274944
(Southern Cross Diagnostics Pty Ltd - Parasitic infectious diseases IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
An internal investigation identified that products 9450, batch number 2419S, had low optical densities in their weak positive control serums. This resulted in an increased index of the patient sample and false positive interpretations. The cause was found to be a chemical component in the control serum buffer. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to:
1. All opened or not yet used kits should be quarantined immediately.
2. Notify clinicians of results transmitted with this batch.
3. Fill-in and send the confirmation of receipt to Bordier Affinity Products by email or fax.
4. Replace all control serum tubes in their quarantined kits with the replacement tubes after they receive the replacement tubes.
5. Retest all samples analyzed with these batches with a corrected kit.
6. Make sure all the relevant people in the organisation are aware of the safety information.
7. Provide a copy of the acknowledgement of receipt in case of a documentation audit. |
| Contact Information |
Customer Service
02 9666 7776
info@scdiagnostics.com.au |