Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
FDA device recall Z-2533-2024 · posted 2024-08-08 · Open, Classified
Recall details
- Recalling firm
- Luminex Corporation
- Reason for recall
- Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
- Action taken
- Diasorin sent a recall notification on 06/20/2024, via email. Consignees were instructed to examine inventory and quarantine any affected units, arrange for replacement and confirm disposal of any of affected units on hand. Customers were asked to perform a retrospective review of results for VERIGENE Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) to look for any false positives, distribute the notification to any relevant personnel, notify consignees if further distributed and complete and return the "Acknowledgement & Receipt Form."
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- PAM
- Quantity affected
- 1,100 kits
- Distribution
- US Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, MS, NE, NV, OH, OK, SC, TN, TX, VA, VT, WA, WV.
- Date initiated
- 2024-06-20
- Date posted
- 2024-08-08
- Location
- Northbrook, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (K122514) | Nanosphere, Inc. | 2012-09-19 |