Medical device control product pouches mislabeled with incorrect catalog number
Microbiologics Inc recalls KWIK-STIK IVD control product (lot 323-108-7) containing 47 packs due to pouches being labeled with incorrect catalog number 726-57-10 instead of correct labeling.
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 medical device recall involving a labeling error on product pouches. Class III recalls are typically assigned lower severity scores. No illnesses, injuries, or adverse events have been reported. The issue is limited to incorrect labeling on the pouch rather than a defect in the product itself.
Plain-English summary
KWIK-STIK is an in vitro diagnostic (IVD) control product containing Enterobacter cloacae bacteria, used by diagnostic laboratories to verify the accuracy of bacterial culture testing procedures. Microbiologics Inc manufactures this quality-control product, which is packaged 2 units per pack.
The recall affects 47 packs (94 individual units) from lot 323-108-7. Products from this lot were packaged in pouches labeled as '726-57-10,' which is not the correct labeling for this product. The labeling discrepancy could lead to misidentification of the control material in diagnostic laboratory settings.
The affected products were distributed to diagnostic laboratories in the United States (California, Florida, Hawaii, Michigan, North Carolina, New Hampshire, New Jersey, Oklahoma, Oregon, Tennessee) and internationally to Canada, Ecuador, France, India, Indonesia, Ireland, Japan, Mexico, South Africa, United Arab Emirates, and Vietnam.
Laboratories that received products from this lot are advised to check their inventory. Affected products can be identified by Lot Number 323-108-7, Catalog Number 0323P, and UDI 20845357006381.
The recalled product
- Product
- KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
- Manufacturer
- Microbiologics Inc
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)
- Catalog Number: 0323P
- Lot Number: 323-108-7
- UDI: 20845357006381
Distribution
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