CLASS II Device recall · Reported 6 Jul 2016 · FDA Enforcement Report
Liquid stable 2 part Homocysteine Reagent recalled by Medtest Holdings
Medtest Holdings is recalling Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of, distributed in Illinois, Michigan, Minnesota, New Jersey, New York. The recall was initiated on 3 Apr 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2063-2016
- FDA event ID
- 74234
- Recalling firm
- Medtest Holdings, Canton, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Apr 2015
- FDA classified
- 28 Jun 2016
- Reported
- 6 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Apr 2015 | Recall initiated by company | |
| 28 Jun 2016 | Classified by FDA | +452 days |
| 6 Jul 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
MI, MN, NJ, IL, NY. US Only.
Questions about this recall
Is Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of recalled?
Yes. Medtest Holdings recalled Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of on 3 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-2063-2016.
Why was it recalled?
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.
Which lots are affected?
Model: H7575-57 Lot: 416703 Expiration date: 2016-01
Where was it sold?
MI, MN, NJ, IL, NY. US Only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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