| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01186-1 |
| Product Name/Description |
ZYM B, API Listeria and API NH (bacterial identification reagents and kits). An in vitro diagnostic medical device (IVD)
ZYM B reagent (Ref Number: 70493)
Multiple lot numbers affected
Used as an additional test in:
- API 20 Strep (Ref Number: 20600)
- API Coryne (Ref Number: 20900)
- API Staph (Ref Number: 20500)
- API ZYM (Ref Number: 25200)
API NH (Ref Number: 10400)
Multiple lot numbers affected
API Listeria (Ref Number: 10300)
Multiple lot numbers affected |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
BioMérieux identified a visual defect and activity issue on the ZYM B reagent (Reference 70493) which is used as an additional test for revealing the results of some miniaturised biochemical tests. Further investigations performed by bioMerieux Quality Control Laboratory confirmed an activity issue on ZYM B reagent. This activity issue lead to a false negative result of some API biochemical tests using the ZYM B reagent. Investigations are still in progress in order to identify the root cause. |
| Recall Action |
Recall |
| Recall Action Instructions |
BioMerieux is advising end users to discard any ampoule of ZYM B with a visual defect (as described in the IFU). For units of ZYM B without the visual defect, end users are requested to carry out additional QC when using the potentially affected API kits. If QC fails the kits are to be discarded. Alternatively any kits of ZYM B can be discarded and replaced by bioMerieux. |
| Contact Information |
1800 333 421 - Biomerieux Australia Technical Assistance Department |