The Recall Desk

FDA (Devices) recall action 89451

Microbiologics Inc recalled 3 products on 2022-03-09

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2022-03-09
Critical
0
Units
2,176

Why these products were recalled

This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.

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.

1–3 of 3

  • HighFDA (Devices)··2022-03-09

    Quality Control Kit Bacterial Strain Shows Unexpected Gentamicin Susceptibility

    Microbiologics has recalled KWIK-STIK quality control kits due to a specific lot failing to meet resistance specifications for Gentamicin Synergy. The affected bacterial strain showed unexpected susceptibility when it should have been resistant.

    Product
    KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2022-03-09

    LYFO-DISK Quality Control Kit Lot Fails Antibiotic Resistance Specification

    A lot of LYFO-DISK quality control kit was found susceptible to Gentamicin Synergy when it should have been resistant. The 153 affected units were distributed worldwide.

    Product
    LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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.

    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
    0 states