Device product
KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
Z-0641-2022
Product summary
- Event
- Event 89479
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10 units
- Official record key
device-enforcement:Z-0641-2022
Official wording
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.
Code information: Catalog Number 01023P, UDI: 20845357029502, Lot Number (Expiration Date): 1023-05-7 (04/30/2014)
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, South Africa, France, Netherlands, Mauritius, China.
Derived failure modes
-
Labeling or packaging
labeling error