Microbiology quality control kit recalled for incorrect inner label
A KWIK-STIK quality control kit has an incorrect inner label. The product contains Campylobacter coli, but the inner label states Haemophilus influenzae.
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: This is an FDA Class III recall with a labeling error. The actual microorganism in the product is correct (Campylobacter coli); only the inner label identification is incorrect. No illnesses, injuries, or deaths have been reported. Class III recalls with labeling errors and no reported harm are typically classified as Low severity.
Plain-English summary
Microbiologics Inc is recalling certain KWIK-STIK Catalog #01023P quality control kits for culture media. The affected product is Lot #1023-05-7 (expiration date 04/30/2014). Some units contain an inner label that incorrectly identifies the microorganism as Catalog #0919K Haemophilus influenzae.
The actual organism contained in the recalled kits has been confirmed to be Campylobacter coli, which is the correct organism for this product. The issue is limited to the inner label identification; the microorganism content itself is correct.
The recalled quality control kits were distributed worldwide, including throughout the United States and internationally to Canada, South Africa, France, Netherlands, Mauritius, and China. These kits are used in laboratory settings to validate culture media and microbiological testing procedures.
The recalled product
- Product
- KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
- Manufacturer
- Microbiologics Inc
- Hazard
- Affected units
- 10
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 01023P
- UDI: 20845357029502
- Lot Number (Expiration Date): 1023-05-7 (04/30/2014)
Distribution
Distributed nationwide across the United States.
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