KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
FDA Recall Z-0544-2022 · Posted 2022-01-31
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Recalling FirmMicrobiologics Inc
Recall StatusTerminated
Product CodeJTR
Date Initiated2021-02-24
Date Terminated2022-07-11
Product Quantity47 packs (94 units)
Reason for Recall
Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
Firm Action
Microbiologics notified customers on about 02/24/2021 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions were to:
1. REVIEW lab procedures to understand how this information affects your usage;
2. USE OR DISCARD depending on your lab procedures and how this information affects your usage;
3.COMPLETE the response form provided;
4. RETURN the response form to [email protected];
5. KEEP this letter for your records;
6. CONTACT Microbiologics if a replacement kit is needed.
Questions or concerns can be directed to Recall Support team at 320.229.7073 or [email protected].
Root Cause
Labeling mix-ups
Distribution Pattern
US distribution to CA, FL, HI, MI, NC, NH, NJ, OK, OR, TN. International distribution to Canada, Ecuador, France, India, Indonesia, Ireland, Japan, Mexico, South Africa, United Arab Emirates, Vietnam.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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