| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00831-1 |
| Product Name/Description |
Haemophilus Test medium (HTM). An in vitro diagnostic medical device (IVD)
Product Number: 04054
Lot Number: HDK-206
ARTG Number: 201986 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
bioMérieux have received reports regarding an issue with the use of the 04054 Haemophilus Test Medium. (Lot Number HDK-206). The issue is related to the media not supporting the growth of Haemophilus influenza isolates (ATCC 49766 and ATCC 49247). |
| Recall Action |
Recall |
| Recall Action Instructions |
bioMérieux is requesting Customers cease using lot number HDK-206 (04054 Haemophilus Test medium). It is also recommended that results which have an ongoing clinical impact be re- examined using a different lot number of 04054 Haemophilus Test medium.
Distribute this information to all appropriate personnel in your laboratory including others to whom you may have transferred the product, retain a copy in your files.
2. Discuss any concerns you may have regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action.
3. Quarantine inventory of 04054 Haemophilus Test medium (HTM) for Lot # HDK-206 and discard all affected products in an appropriate manner.
Please complete and return the acknowledgement form to qa.anz@biomerieux.com to confirm receipt and credit.
This action has been closed out on 30/07/2019 |
| Contact Information |
1800 333 421 - bioMérieux Help Desk Department |