Medtest Homocysteine Reagent Recalled for Performance Deterioration
Medtest Holdings is recalling 13 kits of Liquid Stable 2-Part Homocysteine Reagent due to under-recovery of homocysteine in patient samples.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a performance defect that could lead to inaccurate clinical results, fitting the 'High' category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtest Holdings, Inc. is recalling 13 kits of Liquid Stable 2-Part Homocysteine Reagent (Model H7575-57, Lot 416703, Expiration 2016-01). The product is used for the in vitro quantitative determination of total homocysteine in human serum and plasma. The affected lots were distributed in Michigan, Minnesota, New Jersey, Illinois, and New York.
The recall was initiated because the reagent showed deterioration in assay performance, specifically under-recovery of homocysteine in controls and patient samples. The manufacturer attributed this issue to a loss of reductant activity in Reagent 1. Testing indicated that the affected lot is at the limit of acceptable clinical performance across the reportable range of the assay.
Users should stop using the affected reagent lot. Test data generated to date is considered acceptable if validity control specifications were met.
The recalled product
- 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.
- Manufacturer
- Medtest Holdings, Inc.
- Hazard
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model: H7575-57 Lot: 416703 Expiration date: 2016-01
Distribution
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