| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00703-1 |
| Product Name/Description |
MRSASelect II agar. An in vitro diagnostic medical device (IVD).
Catalogue Numbers: 63757 & 63759
Multiple Lot Numbers
ARTG Number: 188609
(Bio-Rad Laboratories - Microbiological culture media IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Bio-Rad have identified that certain lots of MRSASelect II agar may have abnormal colouration and growth of non-characteristic MRSA colonies.
If plates were exposed to light but none defects have been detected before use, then MRSA colonies may appear white to yellow instead of the pink characteristic colour, or the growth may be delayed. As a result, there is a risk of misinterpretation of the result. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Bio-Rad is advising:
- For the references and batches of affected product, do not expose the boxes more than 4 hours to light during the intermediate storage steps, including returning at room temperature, and during incubation until the reading step.
- Do not use a suspicious colour agar.
- As recommended in the package insert, if in doubt, confirm the identification of colonies by coagulase test or Pastorex Staph Plus.
This action has been closed out on 19/10/2018 |
| Contact Information |
1800 224 354 - Bio-Rad Laboratories |