The Recall Desk

FDA (Devices) recall action 89412

Microbiologics Inc recalled 2 products on 2022-02-16

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2022-02-16
Critical
0
Units
3

Why these products were recalled

Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

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.

1–2 of 2

  • ModerateFDA (Devices)··2022-02-16

    LYSO Disk microorganism culture device mislabeled with incorrect strain

    Microbiologics' LYSO Disk culture disks labeled as containing Actinomyces odontolyticus have been found to actually contain Eggerthella lenta. The mislabeling affects products distributed to Canada and Germany.

    Product
    LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2022-02-16

    Microbiologics Recalls KWIK-STIK Microorganism Reference Material Due to Organism Mislabeling

    Microbiologics Inc is recalling KWIK-STIK microorganism reference kits labeled as Actinomyces odontolyticus but containing Eggerthella lenta. The mislabeling could cause incorrect organism identification in laboratory testing.

    Product
    KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccan
    Category
    Distribution
    0 states