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U.S. Department of Health and Human Services

Class 2 Device Recall Liquid Stable 2Part Homocysteine Reagent

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  Class 2 Device Recall Liquid Stable 2Part Homocysteine Reagent see related information
Date Initiated by Firm April 03, 2015
Create Date June 28, 2016
Recall Status1 Terminated 3 on July 05, 2016
Recall Number Z-2063-2016
Recall Event ID 74234
510(K)Number K083222  
Product Classification Urinary homocystine (nonquantitative) test system - Product Code LPS
Product Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.
Code Information Model: H7575-57 Lot: 416703 Expiration date: 2016-01
Recalling Firm/
Manufacturer		 Medtest Holdings, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact Customer Support
800-445-9853
Manufacturer Reason
for Recall		 Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay performance manifesting itself by under recovery of Homocysteine in Controls and Patient Samples. The cause of this deterioration has been attributed to a loss of reductant activity in Reagent 1. Testing performed indicated that the affected lot is at the limit of acceptable clinical performance. This observation was consistent across the reportable range of the assay. For this reason, do not continue to use affected reagent lot. Test data generated to date will be acceptable where validity control specifiCations have been met.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action On 4/3/2015, Urgent Field Safety Notice notifications were sent to the affected customers via email with instructions for identifying and destroying the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Quantity in Commerce 13
Distribution MI, MN, NJ, IL, NY. US Only.
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 = LPS and Original Applicant = AXIS-SHIELD DIAGNOSTICS, LTD.
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