Culture media quality control kits recalled over mislabeled lot numbers on pouches
Microbiologics is recalling 5 KWIK-STIK quality control kits because some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
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 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: Scored 2 under the minor labeling criterion: the record cites a lot number mismatch on the pouch with no stated consequence or reported harm.
Plain-English summary
KWIK-STIK, a quality control kit for culture media containing Vibrio parahaemolyticus derived from ATCC 17802, catalog number 0818K, is being recalled. The product carries UDI-DI 30845357020018.
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
The recall covers 5 units from lot 818-111-7. Distribution was international, to the United Arab Emirates, China, Singapore and Kazakhstan. The FDA has classified the action as Class II.
The record describes a lot labelling mismatch on the pouch and does not state a further consequence or report injuries. Laboratories should follow Microbiologics' instructions.
The recalled product
- Product
- KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
- Manufacturer
- Microbiologics Inc
- Affected units
- 5
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 (2)
- UDI-DI: 30845357020018
- Lot Number: 818-111-7
Distribution
Distribution scope not specified by the agency.
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