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.
Enforcement
- Recall Number
- Z-2063-2016
- Event ID
- 74234
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtest Holdings, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- July 6, 2016
- Initiation Date
- April 3, 2015
- Classification Date
- June 28, 2016
- Termination Date
- July 5, 2016
- Address
- 5449 Research Dr, Canton, MI, 48188-2261, United States
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.
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.
Model: H7575-57 Lot: 416703 Expiration date: 2016-01
MI, MN, NJ, IL, NY. US Only.
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