Sterling Diagnostics, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0931-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: July 20, 2016

Date Posted: January 4, 2017

Recall Number: Z-0931-2017

Event ID: 75591

Reason for Recall:

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.

Status: Terminated

Product Quantity: 182

Code Information:

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

Distribution Pattern:

Domestic: MI Foreign: Phillipines VA/DOD: None

Voluntary or Mandated:

Voluntary: Firm initiated