Recall Z-0641-2022 ยท JTR Kit, Quality Control For Culture Media
Microbiologics Inc
KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
| Date | Mar 25, 2013 |
| Status | Terminated |
| Reason | Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism. |
| Root cause | Labeling mix-ups |
| Action | Microbiologics notified customers on 03/25/2013 via letter titled "Important Medical Device Correction". Instructions included to inspect inventory for affected products. If customers have received the product identified within the recall (KWIK-STIK" 01023P, Lot# 1023-05-7), it is recommended that the customer destroys the product. Microbiologics shall replace the destroyed product upon confirmation of destruction. Questions or concerns can be directed to the Customer Service Manager at 320.229.7057. |
| Quantity | 10 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, South Africa, France, Netherlands, Mauritius, China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K861022 | KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS Micro-Bio-Logics, Apr 4, 1986 |