The Recall Desk
ModerateFDA (Devices)·Z-2576-2023·Announced 2023-09-20

Microbiologics KWIK-STIK ANA quality control set missing strain

Microbiologics Inc is recalling one lot of KWIK-STIK ANA QC sets missing one of three bacterial strains required for microbiological testing.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III device recall with no reported illnesses or injuries. The defect is a missing component from a quality control testing set. FDA Class III recalls typically score 1 or 2; the missing essential component warrants a Moderate (2) rating.

Plain-English summary

Microbiologics Inc is recalling one lot of KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P, which is used for quality control testing in microbiological laboratories.

One lot (5065-26, Exp. 07/31/2024) is missing one of the three required bacterial strains: 6018P Parabacteroides distasonis. Without all three strains, the quality control set cannot provide complete testing verification as intended.

The affected lot was distributed nationwide to customers in Minnesota, Pennsylvania, Tennessee, and Texas. This is a Class III device recall. No illnesses or injuries have been reported to date. Users of this product should verify the lot number and contact the manufacturer if their units are affected.

The recalled product

Product
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Manufacturer
Microbiologics Inc
Category
Medical Device — Microbiological Quality Control Testing Set
Hazard
  • missing-component

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDI/DI 70845357025622
  • Lot Number 5065-26
  • Exp. 07/31/2024

Distribution

Distributed nationwide across the United States.

Related recalls

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