Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homoc...
FDA Device Recall #Z-2063-2016 — Class II — April 3, 2015
Recall Summary
| Recall Number | Z-2063-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 3, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtest Holdings, Inc. |
| Location | Canton, MI |
| Product Type | Devices |
| 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.
Lot / Code Information
Model: H7575-57 Lot: 416703 Expiration date: 2016-01
Other Recalls from Medtest Holdings, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0389-2019 | Class III | Pointe Scientific AutoHDL/LDL Cholesterol Calib... | Aug 10, 2018 |
| Z-2316-2017 | Class III | MedTest DX Assayed Human Multi Sera Control Lev... | Oct 23, 2014 |
| Z-2121-2017 | Class III | Pointe Scientific Chemistry Controls Level I an... | May 15, 2014 |
| Z-2586-2017 | Class II | Pointe Scientific Hitachi Total Bilirubin Rl Re... | Mar 13, 2012 |
| Z-2116-2017 | Class III | Pointe Scientific Hitachi AST Reagent R1 : P... | Feb 15, 2012 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.