Z-0931-2017Class III

Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative...

Name: Z-0931-2017 Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative...
Creator: Sterling Diagnostics, Inc.
Published: 2016-07-20
License: https://open.fda.gov/license/

Sterling Diagnostics, Inc. / initiated 2016-07-20 / Terminated

FDA source

Sterling Diagnostics, Inc. began a recall of Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a... on 2016-07-20. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0931-2017
Classification: Class III
Status: Terminated
Initiated: 2016-07-20
Posted: 2016-12-29
Terminated: 2017-03-22
Recalling firm: Sterling Diagnostics, Inc.
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.
Product code: CGX Alkaline Picrate, Colorimetry, Creatinine
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.
FDA root cause: Process change control
Action: Sterling Diagnostics, Inc. initiated their voluntary recall on 07/20/2016 by calling customers by phone to determine what kits remianed at customers' and compare withthe firm's sales records. Sterling Diagnostics followed up by sending a letter to each customer, and instructed them to take note of the corrected expiration dates for the dignostic kits, apply the revised dates to the kits in their possession, and return a customer acknowledgement to the Office Manager Luz Santa Maria at Sterling Diagnostics, Inc. at 36645 Metro Court, Sterling Heights, MI 48312. Customers with questions can call 586-979-2141.
Quantity in commerce: 182
Distribution: Domestic: MI Foreign: Phillipines VA/DOD: None
Product codes and lots: Creatinine/Endpoint [Modified Heinegard-Tiderstrom], CAT No. 2167-O, Lot No. 16751, Expriry: 5/18, Manufactured: 06/02/15

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0931-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0929-2017	Class III	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-29
Z-0930-2017	Class III	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-29
Z-0931-2017	Class III	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-29
Z-0932-2017	Class III	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-29
Z-0933-2017	Class III	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-29
Z-0934-2017	Class III	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-29
Z-0935-2017	Class III	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-29
Z-0936-2017	Class III	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-29
Z-0937-2017	Class III	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-29

Product code CGX

K860418Class IICreatinine Reagent SetSterling Diagnostics, Inc. / cleared 1986-02-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)