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U.S. Department of Health and Human Services

Class 3 Device Recall Sterling Diagnostics, Inc., Colorimetric SGOT

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  Class 3 Device Recall Sterling Diagnostics, Inc., Colorimetric SGOT see related information
Date Initiated by Firm July 20, 2016
Date Posted December 29, 2016
Recall Status1 Terminated 3 on March 22, 2017
Recall Number Z-0934-2017
Recall Event ID 75591
510(K)Number K860216  
Product Classification Diazo, ast/sgot - Product Code CIQ
Product Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Code Information Colorimetric SGOT, CAT No. 2250-O, Lot No. 20051, Expriry: 1/19, Manufactured: 01/11/16   
Recalling Firm/
Manufacturer		 Sterling Diagnostics, Inc.
36645 Metro Ct
Sterling Heights MI 48312-1009
For Additional Information Contact Luz I. Santa Maria
586-979-2141
Manufacturer 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 Determined
Cause 2		 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 165
Distribution Domestic: MI Foreign: Phillipines VA/DOD: None
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CIQ and Original Applicant = STERLING DIAGNOSTICS, INC.
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