KWIK-STIK Quality Control Sets recalled for potential bacterial contamination
Microbiologics Inc is recalling KWIK-STIK QC Sets and Panels due to potential contamination with E. coli and Staphylococcus species. The affected product was distributed worldwide to laboratory testing facilities.
What this means for you
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: Potential contamination by E. coli, a high-risk pathogen explicitly cited in the High severity criterion, in an FDA Class II medical device. No reported illnesses, injuries, or confirmed adverse events; the contamination is precautionary.
Plain-English summary
Microbiologics Inc is recalling KWIK-STIK QC Sets and Panels (2-pack quality control microorganism sets for laboratory use) due to potential contamination with Escherichia coli, Staphylococcus epidermidis, and Staphylococcus warneri. These bacteria may compromise the accuracy of laboratory quality control testing.
The recall affects 11 units across two lot numbers: 5193-10 (expiration 09/30/2021) and 5193-11 (expiration 04/30/2021). The product was distributed worldwide, including 39 U.S. states and 28 countries internationally.
Laboratories receiving these products should cease use immediately and contact Microbiologics Inc for replacement or return instructions. No illnesses, testing failures, or other adverse events have been reported to date. This recall is precautionary to prevent potential quality control failures in laboratory testing.
The recalled product
- Product
- QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that conta
- Manufacturer
- Microbiologics Inc
- Affected units
- 11
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)
- Catalog Number: 5193P
- Lot Number: 5193-10 (Expiration Date 09/30/2021)
- 5193-11 (Expiration Date 04/30/2021)
- UDI: 70845357030718
Distribution
Part of a larger recall action
This product is one of 3 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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