Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bott...
FDA Device Recall #Z-2764-2015 — Class III — March 13, 2015
Recall Summary
| Recall Number | Z-2764-2015 |
| Classification | Class III — Low risk |
| Date Initiated | March 13, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Pointe Scientific, Inc. |
| Location | Canton, MI |
| Product Type | Devices |
| Quantity | H7545-R1, 8.75 L; 12-H7545-162, 4 kits; H7545-1000, 3 kits; HDL600, 6 kits |
Product Description
Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP plastic caps. Bulk: PE plastic cube containers, PP plastic caps. Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.
Reason for Recall
Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.
Distribution Pattern
Worldwide Distribution - US including MI, FL, CA, TX, CT, PR and Internationally to Canada.
Lot / Code Information
Catalog numbers: H7545-R1, 12-H7545-162, H7545-1000, HDL600 Lot number: 430402
Other Recalls from Pointe Scientific, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2487-2015 | Class II | Pointe Scientific G6PD Controls Kit configurat... | May 19, 2015 |
| Z-2773-2015 | Class III | Pointe Scientific Creatinine Reagent Catalog n... | Dec 12, 2014 |
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.