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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DKJ
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