Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic...
FDA Device Recall #Z-2116-2017 — Class III — February 15, 2012
Recall Summary
| Recall Number | Z-2116-2017 |
| Classification | Class III — Low risk |
| Date Initiated | February 15, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtest Holdings, Inc. |
| Location | Canton, MI |
| Product Type | Devices |
| Quantity | 119.168L across All lots |
Product Description
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
Reason for Recall
A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k submission package insert.
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
Catalog numbers: HA461, HA761 , HA961 and lot codes:022204, 034801, 102401, 119503, and 134101.
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-2063-2016 | Class II | Liquid stable 2 part Homocysteine Reagent, for ... | Apr 3, 2015 |
| 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 |
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.