| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01270-1 |
| Product Name/Description |
API ZYM B. An in vitro diagnostic medical device (IVD)
Product Code: 70493
Multiple Lot numbers affected
ARTG Number: 232822 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
Based on discrepant results (False negative results) reported from the field, bioMérieux initiated a complaint investigation to confirm product performance and determine root cause. The investigation confirmed a loss of performance after 3 months of shelf life for API ZYM B, which led to False Negative results on some API strips using the ZYM B reagent. As a result of the ZYM B performance shift, the risk is to potentially report a false negative result of some API tests; misidentification of some species with API 20 Strep, API NH, API Listeria and API Coryne. API Staph is not impacted by a risk of misidentification. Regarding API ZYM, as it is designed for the research of enzymatic activities, there is no risk of microorganism misidentification. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Biomerieux is advising users to perform quality control with ATCC strains prior to using the ZYM B ampule.
A review of previously reported results is recommended at the discretion of the Laboratory Director. |
| Contact Information |
1800 333 421 – Biomerieux Help Desk Department |