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Terminated

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.

FDA Recall Z-0932-2017 · Posted 2016-12-29

Recalling FirmSterling Diagnostics, Inc.
Recall StatusTerminated
Product CodeCGA
Date Initiated2016-07-20
Date Terminated2017-03-22
Product Quantity40

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.

Firm 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.

Root Cause

Process change control

Distribution Pattern

Domestic: MI Foreign: Phillipines VA/DOD: None

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K854335GLUCOSE REAGENT SET (GOD/TRINDER)Sterling Diagnostics, Inc. · 1985-11-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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