Microbiologics KWIK-STIK Candida Parapsilosis Control Has Incorrect Pouch Labeling
Microbiologics is recalling KWIK-STIK Candida parapsilosis diagnostic controls with lot 726-57-10 because some pouches are labeled with incorrect catalog number (323-108-7 instead of 0726P).
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recall involving a packaging and labeling discrepancy with no reported illnesses, injuries, or health hazards. The issue is a documentation error on the pouch label rather than a defect in the product itself.
Plain-English summary
Microbiologics Inc is recalling KWIK-STIK Candida parapsilosis in vitro diagnostic (IVD) controls with lot number 726-57-10 because some pouches may be labeled with an incorrect catalog number (323-108-7 instead of the correct 0726P). The recall affects 65 packs, each containing 2 units, distributed worldwide.
The affected product has been distributed to facilities in the US states of Georgia, Mississippi, Montana, North Carolina, New Mexico, Nevada, Tennessee, Texas, Washington, and Wisconsin. International distribution includes Brazil, Canada, China, Colombia, Dominican Republic, France, India, Ireland, Japan, Mexico, Oman, Philippines, Romania, South Africa, Turkey, and the United Arab Emirates.
Laboratory professionals using this product should verify that pouch labels match the actual contents and intended use before performing tests. If you have product from lot 726-57-10, check your purchase records and contact Microbiologics Inc for further guidance.
The recalled product
- Product
- KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
- Manufacturer
- Microbiologics Inc
- Hazard
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: 0726P
- Lot Number: 726-57-10
- UDI: 20845357017486
Distribution
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