The Recall Desk
HighFDA (Devices)·Z-0588-2022·Announced 2022-02-16

Diagnostic Quality Control Microorganism Set Fails Gentamicin Susceptibility Specifications

Microbiologics Inc is recalling 139 units of KWIK-STIK AST-GP QC microorganism sets due to incorrect susceptibility test results. The products failed gentamicin synergy specifications and could affect the accuracy of laboratory diagnostic testing.

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 essential to diagnostic accuracy. The product failed to meet specifications and could affect laboratory diagnostic test validation. No illnesses or injuries have been reported, and the hazard is potential rather than demonstrated.

Plain-English summary

Microbiologics Inc is recalling 139 units of KWIK-STIK AST-GP (6 Strains) QC Sets, Catalog Number 5220P. These are quality control microorganisms used by clinical laboratories to verify that antibiotic susceptibility diagnostic tests are working correctly.

The recalled lots (5220-01 through 5220-06) failed quality control testing. When analyzed on the Vitek 2 AST-GP67 card, the High Level Gentamicin Synergy value was out of specification, and the lots also failed the disk diffusion testing method required for product release.

Quality control products are essential to diagnostic accuracy. When they fail to meet specifications, laboratories may not properly validate their own diagnostic tests, which could result in undetected diagnostic failures.

The affected product has been distributed worldwide to 56 countries, including the United States, Puerto Rico, and Guam. Laboratories and healthcare facilities using these affected lots should discontinue use immediately and contact Microbiologics Inc for replacement or credit.

The recalled product

Product
QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Manufacturer
Microbiologics Inc
Category
Medical Device — Diagnostic Quality Control
Hazard
  • specification-failure
  • diagnostic-accuracy

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 (8)

  • Catalog Number: 5220P
  • Lot Numbers (Expiration Date): 5220-01 (04/30/2020)
  • 5220-02 (07/31/2020)
  • 5220-03 (10/31/2020)
  • 5220-04 (10/31/2020)
  • 5220-05 (10/31/2020)
  • 5220-06 (01/31/2021)
  • UDI: 70845357026551

Distribution

Distributed nationwide across the United States.

Related recalls

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