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U.S. Department of Health and Human Services

Class 2 Device Recall DRI Salicylate Serum Tox Assay

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  Class 2 Device Recall DRI Salicylate Serum Tox Assay see related information
Date Initiated by Firm July 25, 2016
Date Posted September 23, 2016
Recall Status1 Terminated 3 on November 21, 2016
Recall Number Z-2884-2016
Recall Event ID 74861
510(K)Number K961131  
Product Classification Colorimetry, salicylate - Product Code DKJ
Product DRI Salicylate Serum Tox Assay, Catalog number 0977.

Toxicology:
The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.
Code Information Lot Number Expiration Date 60704602 DEC 2016; 72035410 JUL 2017; 72208738 FEB 2018; 72409454 OCT 2018.
Recalling Firm/
Manufacturer		 Microgenics Corporation
46500 Kato Rd
Fremont CA 94538-7310
For Additional Information Contact Jeffrey J. Fisher
510-979-5000
Manufacturer Reason
for Recall		 Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Thermo Fisher Scientific, sent an "URGENT MEDICAL DEVICE FIELD ACTION" letter dated July 25, 2016 by regular mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to determine if they are using or have inventory of any of the affected lots; discontinue use and destroy any remaining inventory of affected lots per local wastes ordinances; retain a copy of the letter for laboratory records; if you have forwarded kits of the affected lots, provide a copy of letter to them; and complete and return attached Medical Device Field Action Response Form within 5 days to Thermo Fisher Scientific Technical Service via fax at 1-888-527-8001 (USA toll free), 510-979-5420 (outside of USA) or email to techservice.mgc@thermofisher.com. If you have any questions contact Technical Services at 1-800-232-3342 (USA only) or 510-969-5000 (outside the USA) press option 2 then option 3.
Quantity in Commerce 1708 kits
Distribution Worldwide Distribution: US (nationwide) to states of: AZ, CA, MO, TX, and PR and countries of: Canada, Germany, Hong Kong, Italy, Malaysia, and Taiwan.
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 = DKJ and Original Applicant = DIAGNOSTIC REAGENTS, INC.
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