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.
This recall has been terminated (originally issued December 29, 2016).
- Company
- Sterling Diagnostics, Inc.
- Recall Initiated
- July 20, 2016
- Posted
- December 29, 2016
- Terminated
- March 22, 2017
- Recall Number
- Z-0931-2017
- Quantity
- 182
- Firm Location
- Sterling Heights, MI
- Official Source
- View on FDA website ↗
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
Domestic: MI Foreign: Phillipines VA/DOD: None
Lot / Code Info
Creatinine/Endpoint [Modified Heinegard-Tiderstrom], CAT No. 2167-O, Lot No. 16751, Expriry: 5/18, Manufactured: 06/02/15
Root Cause
Process change control
Action Taken
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.