Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic ...
FDA Device Recall #Z-2121-2017 — Class III — May 15, 2014
Recall Summary
| Recall Number | Z-2121-2017 |
| Classification | Class III — Low risk |
| Date Initiated | May 15, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtest Holdings, Inc. |
| Location | Canton, MI |
| Product Type | Devices |
| Quantity | 132919 Vol vials |
Product Description
Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.
Reason for Recall
The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.
Distribution Pattern
Nationwide
Lot / Code Information
Model Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II).
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-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.