Z-0641-2022 Class III Terminated
FDA device recall Z-0641-2022 was initiated by Microbiologics Inc on Mar 25, 2013 and is designated Class III. Reason for recall: 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… The recall status is terminated (terminated Apr 22, 2022). Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 23, 2022
- Initiation Date
- Mar 25, 2013
- Termination Date
- Apr 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, South Africa, France, Netherlands, Mauritius, China.
Code Information
Catalog Number 01023P, UDI: 20845357029502, Lot Number (Expiration Date): 1023-05-7 (04/30/2014)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0641-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026