Recall Z-2576-2023 ยท JTR Kit, Quality Control For Culture Media
Microbiologics Inc
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
| Date | Sep 11, 2023 (initiated Aug 14, 2023) |
| Status | Open, Classified |
| Reason | One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis. |
| Root cause | Packaging process control |
| Action | Microbiologics issued an Urgent Medical Device Recall notice to its consignees by email on 08/14/2023. The notice explained the problem with the device and requested the consignee either use or discard the product depending on their lab procedures and how this information affects your usage. Contact Microbiologics if replacement kit is needed. |
| Quantity | 4 units |
| Distribution | US Nationwide distribution in the states of MN, PA, TN, TX. |
| 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 |