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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Hazard
- Affected units
- 4
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
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