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U.S. Department of Health and Human Services

Class 3 Device Recall Sterling Diagnostics, Inc., Enzymatic Glucose

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 Class 3 Device Recall Sterling Diagnostics, Inc., Enzymatic Glucosesee related information
Date Initiated by FirmJuly 20, 2016
Date PostedDecember 29, 2016
Recall Status1 Terminated 3 on March 22, 2017
Recall NumberZ-0932-2017
Recall Event ID 75591
510(K)NumberK854335 
Product Classification Glucose oxidase, glucose - Product Code CGA
ProductSterling 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.
Code Information Enzymatic Glucose, CAT No. 2185-L, Lot No. 18561, Expriry: 5/19, Manufactured: 05/25/16 
Recalling Firm/
Manufacturer		 Sterling Diagnostics, Inc.
36645 Metro Ct
Sterling Heights MI 48312-1009
For Additional Information ContactLuz 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
ActionSterling 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 Commerce40
DistributionDomestic: MI Foreign: Phillipines VA/DOD: None
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CGA
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