The Recall Desk

FDA (Devices) recall action 89401

Microbiologics Inc recalled 5 products on 2022-02-16

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2022-02-16
Critical
0
Units
2,310

Why these products were recalled

Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • HighFDA (Devices)··2022-02-16

    QC Blood Culture Identification Panel Recall for Incorrect Antibiotic Susceptibility Test Results

    Microbiologics recalls KWIK-STIK blood culture identification quality control panels due to incorrect susceptibility test results. High-level Gentamicin Synergy values were out of specification, risking inaccurate diagnostic guidance.

    Product
    QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    QC Control Materials KWIK-STIK AST-GP Produce Incorrect Test Results

    Microbiologics Inc recalls KWIK-STIK AST-GP quality control materials that produce incorrect antibiotic susceptibility test results. Two lot numbers were distributed worldwide.

    Product
    QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
    Category
    Distribution
    2 states
  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2022-02-16

    Diagnostic Control Microorganism Recalled for Incorrect Test Results

    Diagnostic control microorganisms manufactured by Microbiologics Inc are recalled for returning incorrect antibiotic susceptibility test results. These controls failed quality specifications and could cause inaccurate lab test results.

    Product
    LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
    Category
    Distribution
    2 states
  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    2 states