The Recall Desk

Manufacturer

Microgenics Corp

2 recalls in our database name Microgenics Corp as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2013-12-25

Of the 2 recalls from Microgenics Corp we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • ModerateFDA (Devices)·Z-0513-2014·2013-12-25

    Microgenics Recalls CEDIA Tobramycin II Assay Due to Calibration Stability Issues

    Microgenics Corp. is recalling CEDIA Tobramycin II Assay (Lot 60169764) due to a calibration stability problem identified through two customer complaints.

    Product
    Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2267-2013·2013-10-02

    Microgenics Recalls DRI Cocaine Metabolite Assay Due to Reagent Degradation

    Microgenics Corp is recalling specific lots of DRI Cocaine Metabolite Assay because surveillance showed unexpected reagent degradation. The recall affects 1,473 units distributed across multiple US states.

    Product
    DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitativ
    Category
    Medical Device
    Distribution
    21 states