KWIK-STIK Quality Control Kit Recalled for Fungal Contamination
Microbiologics Inc recalls KWIK-STIK quality control kits contaminated with Aspergillus brasiliensis fungus. Users may observe unexpected fungal growth when using affected control material.
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: FDA Class II recall involving contamination with Aspergillus brasiliensis, a high-risk pathogenic fungus, in a quality control kit. No illnesses or injuries have been reported, capping the score at maximum 3 per the rubric.
Plain-English summary
Microbiologics Inc has recalled KWIK-STIK Rhizopus stolonifer quality control kits used to validate culture media in laboratories. The recall affects 19 units distributed nationwide in California, Michigan, Kentucky, Missouri, New Mexico, Tennessee, and Puerto Rico, as well as France, Colombia, Kazakhstan, Peru, and South Africa.
The positive control material in the KWIK-STIK assembly was contaminated with Aspergillus brasiliensis, a fungal organism different from the intended Rhizopus stolonifer. When used for quality control testing, users may observe Aspergillus brasiliensis growth instead of the expected control growth pattern.
Laboratories should cease use of affected lots and verify their testing protocols. This is a Class II medical device recall. No illnesses or injuries have been reported.
The recalled product
- Product
- KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
- Manufacturer
- Microbiologics Inc
- Affected units
- 19
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 (9)
- a) REF 0209P
- UDI/DI 20845357003113
- Lot Numbers: 209-37-1
- 209-37-3
- 209-37-4
- 209-37-5
- b) REF 0209K
- UDI/DI 30845357003127
- Lot Numbers: 209-37-2
Distribution
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