The Recall Desk

FDA (Devices) recall action 86576

Microbiologics Inc recalled 3 products on 2020-11-04

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
2020-11-04
Critical
0
Units
36

Why these products were recalled

KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.

KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.

QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.

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

  • ModerateFDA (Devices)··2020-11-04

    Microbiologics Recalls KWIK-STIK Klebsiella Pneumoniae Culture Units

    Microbiologics Inc is recalling KWIK-STIK Klebsiella pneumoniae units that were confirmed to be NDM-1 negative instead of the required NDM-1 positive strain.

    Product
    Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or f
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-11-04

    Microbiologics Recalls KWIK-STIK Klebsiella Pneumoniae Due to Incorrect Strain

    Microbiologics Inc is recalling KWIK-STIK Klebsiella pneumoniae units because the product was confirmed to be NDM-1 negative instead of the required NDM-1 positive strain.

    Product
    Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or f
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-11-04

    Microbiologics Recalls KWIK-STIK 2 Pack Due to Incorrect NDM-1 Strain

    Microbiologics Inc is recalling KWIK-STIK 2 Pack units where the NDM-1 positive strain was confirmed to be negative.

    Product
    Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or f
    Category
    Distribution
    0 states