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Open, Classified

KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing

FDA Recall Z-2576-2023 · Posted 2023-09-11

Recalling FirmMicrobiologics Inc
Recall StatusOpen, Classified
Product CodeJTR
Date Initiated2023-08-14
Product Quantity4 units

Reason for Recall

One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

US Nationwide distribution in the states of MN, PA, TN, TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K861022KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSMicro-Bio-Logics · 1986-04-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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