The Recall Desk
HighFDA (Devices)·Z-0712-2022·Announced 2022-03-09

KWIK-STIK Quality Control Kit Recalled for Incorrect Antibiotic Susceptibility

Microbiologics Inc is recalling KWIK-STIK quality control kits containing Enterococcus faecalis because certain lots are susceptible to Gentamicin Synergy when they should be resistant. The defect could affect laboratory testing accuracy.

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: FDA Class II recall of a quality control product that does not meet its specified antibiotic resistance profile. While no illnesses or injuries have been reported, faulty quality control results could indirectly compromise laboratory testing accuracy across multiple facilities and countries. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Microbiologics Inc is recalling KWIK-STIK, a quality control kit for culture media containing Enterococcus faecalis. The kits are sold as a 2-pack (Catalog Number 0959P) and a 6-pack (Catalog Number 0959K), with a total of 1,873 units affected.

The Enterococcus faecalis strain in these kits was specified to be resistant to high levels of Gentamicin and resistant to Gentamicin Synergy. During in-house testing, Microbiologics discovered that certain lots were susceptible to Gentamicin Synergy, failing to meet the specified resistance profile. Multiple lot numbers from between 2014 and 2015 are affected.

The affected kits have been distributed worldwide throughout the United States and to more than 40 countries including Argentina, Belgium, Brazil, Canada, China, India, Japan, and many others. Specific affected lot numbers and their expiration dates are available from the FDA recall announcement.

Laboratories and other users who have received affected lots should stop using them immediately and contact Microbiologics Inc for instructions. The incorrect antibiotic resistance profile in the quality control strain could compromise the accuracy of laboratory testing and quality control procedures that depend on these kits.

The recalled product

Product
KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
Manufacturer
Microbiologics Inc
Category
Medical Device — Laboratory Quality Control Kit
Hazard
  • specification-defect
  • incorrect-resistance

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 (19)

  • a. Catalog Number 0959P
  • UDI: 20845357023210
  • Lot Number (Expiration Date): 959-74-2 (10/08/2014)
  • 959-74-3 (10/08/2014)
  • 959-74-7 (10/08/2014)
  • 959-75-4 (04/22/2015)
  • 959-75-8 (04/22/2015)
  • 959-75-9 (04/22/2015)
  • 959-75-14 (04/22/2015)
  • 959-76-1 (07/08/2015)
  • 959-77-3 (10/21/2015)
  • b. Catalog Number 0959K
  • UDI: 30845357023224
  • Lot Number (Expiration Date): 959-74-4 (10/08/2014)
  • 959-74-6 (10/08/2014)
  • 959-74-8 (10/08/2014)
  • 959-75-1 (04/22/2015)
  • 959-75-12 (04/22/2015)
  • and 959-77-1 (10/21/2015)

Distribution

Distributed nationwide across the United States.

Related recalls

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