The Recall Desk
HighFDA (Devices)·Z-0585-2022·Announced 2022-02-16

Quality Control Kit for Antibiotic Susceptibility Testing Returning Incorrect Results

Microbiologics Inc is recalling KWIK-STIK quality control kits used by laboratories because certain lots return incorrect test results that 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: This is a quality control product with a functional defect that could compromise the accuracy of antibiotic susceptibility testing in clinical laboratories. While no illnesses or injuries have been reported, the potential for harm exists if laboratories unknowingly use defective quality control materials. The hazard is significant but theoretical, placing it in the High category per the rubric for risk-of-harm products without reported injury.

Plain-English summary

Microbiologics Inc has recalled KWIK-STIK, a quality control kit for culture media used in laboratories to verify antibiotic susceptibility testing. The product is sold as a 2-pack or 6-pack containing Enterococcus faecalis organisms.

The recall was initiated because certain lots of KWIK-STIK are returning incorrect test results. The Gentamicin-related values in affected lots were found to be out of specification when tested, and the lots failed quality control verification methods used before product release. If laboratories use these faulty quality control materials, they may not properly validate their antibiotic susceptibility testing.

The affected product has been distributed worldwide, including throughout the United States, Puerto Rico, Guam, and over 40 other countries. Approximately 1,975 units have been distributed. Specific lot numbers and expiration dates are available from the FDA.

Laboratories currently using affected lots should discontinue use immediately and contact Microbiologics Inc for replacement or refund. Laboratory directors should review their quality control procedures to ensure proper validation has been performed.

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
Hazard
  • incorrect-test-results
  • quality-control-failure

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 (16)

  • a. Catalog Number 0959P
  • UDI: 20845357023210
  • Lot Number (Expiration Date): 959-94-3 (04/30/2020)
  • 959-95-2 (09/30/2020)
  • 959-96-1 (12/31/2020)
  • 959-96-4 (12/31/2021)
  • 959-97-4 (03/31/2021)
  • 959-97-5 (03/31/2021)
  • b. Catalog Number 0959K
  • UDI: 30845357023224
  • Lot Number (Expiration Date): 959-94-2 (04/30/2020)
  • 959-95-1 (09/30/2020)
  • 959-95-5 (09/30/2020)
  • 959-96-3 (12/31/2020)
  • 959-97-1 (03/31/2021)
  • 959-97-6 (03/31/2021)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category