The Recall Desk

FDA (Devices) recall action 82783

Microbiologics Inc recalled 2 products on 2019-06-12

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
2019-06-12
Critical
0
Units
484

Why these products were recalled

Product with incorrect shelf life.

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

1–2 of 2

  • ModerateFDA (Devices)··2019-06-12

    Microbiologics Recalls Cepheid Xpert MRSA Control Panels Due to Incorrect Shelf Life

    Microbiologics Inc is recalling 249 units of Cepheid Xpert MRSA/MRSA NxG and Xpert SA Nasal Complete Control Panels because they have an incorrect shelf life.

    Product
    Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indi
    Category
    Distribution
    36 states
  • ModerateFDA (Devices)··2019-06-12

    Microbiologics Recalls Cepheid Xpert SA Nasal Control Panels for Shelf Life Error

    Microbiologics is recalling 235 units of Cepheid Xpert SA Nasal Complete Control Panels due to incorrect shelf life labeling.

    Product
    Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM
    Category
    Distribution
    36 states