The Recall Desk

Manufacturer

Genetic Testing Institute,inc

2 recalls in our database name Genetic Testing Institute,inc as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2015-01-28

Of the 2 recalls from Genetic Testing Institute,inc 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-1001-2015·2015-01-28

    Genetic Testing Institute Recalls PF4 Concentrated Wash Reagent Lots

    Genetic Testing Institute is recalling specific lots of PF4 Concentrated Wash (10x) because the reagent is slightly more dilute than intended, which may cause false positive test results.

    Product
    PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) The PF4 IgG assay is an Enzyme Linked Immunosorb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1022-2013·2013-04-03

    Genetic Testing Institute Recalls PF4 Enhanced Assay Kits Due to Invalid Results

    Genetic Testing Institute is recalling 386 lots of LIFECODES PF4 Enhanced assay kits because inconsistent values can lead to invalid test results.

    Product
    Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
    Category
    Medical Device
    Distribution
    Distributed nationwide