| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00804-1 |
| Product Name/Description |
chromID S.aureus agar (SAID/MRSA). An in vitro diagnostic medical device (IVD)
chromID S.aureus agar (SAID)
Lot Numbers: 1004119200, 1004044190, 1004085400
chromID MRSA agar / chromID S. aureus agar (MRSA/SAID)
Lot Numbers: 1004158090, 1004091980, 1004113000, 1004141170
ARTG Number: 182081
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
During an internal investigation, bioMérieux observed an anomaly on nine (9) lots of chromID S. aureus manufactured with the same semi-finished lot.
This anomaly is causing a delayed colouration of the colonies which appear white/light green instead of green resulting in a potential false negative result.
Biochemical and/or immunological tests must be performed to identify colonies other than green ones (white, pink or mauve): therefore, the risk of delivering a false negative result is mitigated if the instructions for use have been followed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Biomerieux is advising users to discontinue use and discard any remaining inventory of the affected product.
Biomerieux advises that users should discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 18/08/2016. |
| Contact Information |
1800 333 421 - bioMerieux Technical Assistance Department |