The Recall Desk

Manufacturer

Greer Laboratories, Inc.

2 recalls in our database name Greer Laboratories, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2022-12-07

Of the 2 recalls from Greer Laboratories, 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

  • HighFDA (Devices)·Z-0347-2023·2022-12-07

    Medical laboratory reagent recalled for potential false-negative test results

    Greer Laboratories recalled a hypersensitivity pneumonitis test reagent (Lot 389591) due to decreased reactivity that could cause false-negative results. The issue affects 218 units distributed across 12 U.S. states and two countries.

    Product
    GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0348-2023·2022-12-07

    Medical device test system recalled for decreased reactivity and false-negative results

    Greer Laboratories recalled a hypersensitivity pneumonitis test kit (102 units, Lot 389592) after stability testing revealed decreased reactivity that could cause false-negative results. The issue was discovered in October 2021.

    Product
    GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
    Category
    Medical Device
    Distribution
    11 states