The Recall Desk

Manufacturer

Sterling Diagnostics, Inc.

9 recalls in our database name Sterling Diagnostics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
0
Most recent
2017-01-04

Of the 9 recalls from Sterling Diagnostics, 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.

1–9 of 9

  • ModerateFDA (Devices)·Z-0930-2017·2017-01-04

    Sterling Diagnostics Recalls HDL Cholesterol Kits Due to Expiration Date Error

    Sterling Diagnostics is recalling HDL Cholesterol diagnostic kits because previously extended expiration dates were rescinded.

    Product
    Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0929-2017·2017-01-04

    Sterling Diagnostics Recalls Enzymatic Cholesterol Diagnostic Kits

    Sterling Diagnostics is recalling 97 units of Enzymatic Cholesterol diagnostic kits due to a revision of previously extended expiration dates.

    Product
    Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0937-2017·2017-01-04

    Sterling Diagnostics Recalls Enzymatic Uric Acid Diagnostic Kits

    Sterling Diagnostics is recalling 173 Enzymatic Uric Acid diagnostic kits because previously extended expiration dates were rescinded.

    Product
    Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0931-2017·2017-01-04

    Sterling Diagnostics Recalls Creatinine Diagnostic Kits Due to Expiration Date Error

    Sterling Diagnostics is recalling 182 units of Creatinine/Endpoint diagnostic kits because previously extended expiration dates were rescinded.

    Product
    Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0934-2017·2017-01-04

    Sterling Diagnostics Recalls Colorimetric SGOT Kits Due to Expiration Date Error

    Sterling Diagnostics is recalling 165 Colorimetric SGOT diagnostic kits because previously extended expiration dates were rescinded.

    Product
    Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0935-2017·2017-01-04

    Sterling Diagnostics Recalls SGPT Colorimetric Kits Due to Expiration Date Error

    Sterling Diagnostics is recalling SGPT Colorimetric kits because previously extended expiration dates were rescinded.

    Product
    Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0936-2017·2017-01-04

    Sterling Diagnostics Recalls Urea Nitrogen Diagnostic Kits Due to Expiration Date Error

    Sterling Diagnostics is recalling 131 Urea Nitrogen diagnostic kits because previously extended expiration dates were rescinded. The kits were distributed in Michigan and the Philippines.

    Product
    Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0932-2017·2017-01-04

    Sterling Diagnostics Recalls Enzymatic Glucose Diagnostic Kits

    Sterling Diagnostics is recalling 40 units of Enzymatic Glucose diagnostic kits due to a revision of previously extended expiration dates.

    Product
    Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0933-2017·2017-01-04

    Sterling Diagnostics Serum Iron/IBC Diagnostic Kits Recalled for Expiration Date Issues

    Sterling Diagnostics is recalling Serum Iron/IBC diagnostic kits because previously extended expiration dates were rescinded.

    Product
    Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state