| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00353-1 |
| Product Name/Description |
Horse Blood Agar. An in vitro diagnostic medical device (IVD)
Reference Number: 04059
Lot Number: JCU-203
ARTG Number: :201986 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
2/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
bioMérieux has identified an issue at their Brisbane Culture Media manufacturing site regarding product reference number 04059, lot number JCU-203, Horse Blood Agar. During post release testing a potential contamination issue (contaminated deep and surface) has been identified. The microorganism was identified as a gram positive bacilli. |
| Recall Action |
Recall |
| Recall Action Instructions |
bioMérieux is requesting that Laboratories should:
1.Stop using HBA ref. 04059, Lot JCU-203 and segregate the product and discard/dispose appropriately under the relevant laboratory guidelines;
2.Complete and return Attachment A from the customer letter to qa.anz@biomerieux.com in order to confirm receipt; and
3.Contact your local bioMérieux representative for product compensation as necessary.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 8852 4700 - bioMérieux |