Home / Recalls / Sterling Diagnostics, Inc. / Z-0931-2017

Z-0931-2017 Class III Terminated

Recalled by Sterling Diagnostics, Inc. — Sterling Heights, MI

Recall Details

Product Type
Devices
Report Date
January 4, 2017
Initiation Date
July 20, 2016
Termination Date
March 22, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
182

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.

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.

Distribution Pattern

Domestic: MI Foreign: Phillipines VA/DOD: None

Code Information

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

Other recalls by Sterling Diagnostics, Inc.

  • Z-0936-2017 Class III — Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the (July 20, 2016)
  • Z-0934-2017 Class III — Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the q (July 20, 2016)
  • Z-0932-2017 Class III — Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in th (July 20, 2016)
  • Z-0935-2017 Class III — Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the (July 20, 2016)
  • Z-0937-2017 Class III — Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO D (July 20, 2016)
  • Z-0930-2017 Class III — Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC (July 20, 2016)
  • Z-0933-2017 Class III — Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC (July 20, 2016)
  • Z-0929-2017 Class III — Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quant (July 20, 2016)