Home / Recalls / Medtest Holdings, Inc. / Z-2063-2016

Z-2063-2016 Class II Terminated

Recalled by Medtest Holdings, Inc. — Canton, MI

Recall Details

Product Type
Devices
Report Date
July 6, 2016
Initiation Date
April 3, 2015
Termination Date
July 5, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13

Product Description

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.

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.

Distribution Pattern

MI, MN, NJ, IL, NY. US Only.

Code Information

Model: H7575-57 Lot: 416703 Expiration date: 2016-01

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