Medical Device Recall: KWIKSTIK Microbiological Reagent Contaminated with Aspergillus
Microbiologics Inc recalls KWIKSTIK microbiological reagent kits due to Aspergillus flavus contamination in bulk pellets. Affected products were distributed worldwide, including the US, Italy, France, Turkey, Peru, and Mexico.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving contamination with Aspergillus flavus, a high-risk pathogenic fungus. No illnesses or injuries have been reported, limiting the score to 3 per rubric guidance.
Plain-English summary
Microbiologics Inc is recalling KWIKSTIK, P. venetum, available in two catalog configurations: 0794P (2-pack) and 0794K (6-pack). These are microbiological reagent products distributed worldwide.
An investigation identified contamination of bulk pellets from lot 794-142 with Aspergillus flavus, a pathogenic fungus. This contamination affects lot numbers 794-142-2, 794-142-3, and 794-142-4.
The contaminated products were distributed worldwide across the United States, Italy, France, Turkey, Peru, and Mexico, with 13 units affected in total. Customers who possess affected lot numbers should not use these products and should contact Microbiologics Inc or the FDA for guidance on return or replacement.
The recalled product
- Product
- KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
- Manufacturer
- Microbiologics Inc
- Affected units
- 13
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 (4)
- a) UDI/DI 20845357019169
- Lot Numbers: 794-142-2
- 794-142-4 b) UDI/DI 30845357019173
- Lot Numbers: 794-142-3
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Microbiologics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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