Sterling Diagnostics, Inc.: Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.

Agency Publication Date: December 29, 2016

Affected Products

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.

Cholesterol, CAT No. 2145-L, Lot No. 14551, Expiry: 11/18, Manufactured: 11/04/15

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.

HDL Cholesterol, CAT No. 2150-P, Lot No. 15051, Expriry: 3/18, Manufactured: 03/10/15

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.

Creatinine/Endpoint [Modified Heinegard-Tiderstrom], CAT No. 2167-O, Lot No. 16751, Expriry: 5/18, Manufactured: 06/02/15

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.

Enzymatic Glucose, CAT No. 2185-L, Lot No. 18561, Expriry: 5/19, Manufactured: 05/25/16

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.

Serum Iron/IBC (Colorimetric), CAT No. 2200-O, Lot No. 20051, Expriry: 5/18, Manufactured: 05/11/15

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.

Colorimetric SGOT, CAT No. 2250-O, Lot No. 20051, Expriry: 1/19, Manufactured: 01/11/16

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.

SGPT Colorimetric, CAT No. 2260-0 , Lot No. 26051, Expriry: 4/18, Manufactured: 04/27/15

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.

Urea Nitrogen/Color BUN, CAT No. 2290-L , Lot No. 29051, Expriry: 9/18, Manufactured: 09/21/15

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.

Urea Nitrogen/Color BUN, CAT No. 2305-O , Lot No. 30551, Expriry: 7/18, Manufactured: 07/21/15

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75591

Status: Resolved

Manufacturer: Sterling Diagnostics, Inc.

Manufactured In: United States

Units Affected: 9 products (97; 245; 182; 40; 51; 165; 51; 131; 173)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products