Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2...
FDA Device Recall #Z-2487-2015 — Class II — May 19, 2015
Recall Summary
| Recall Number | Z-2487-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 19, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Pointe Scientific, Inc. |
| Location | Canton, MI |
| Product Type | Devices |
| Quantity | 2772 total vials (374 kits of 6 vials, 528 invidually sold vials) |
Product Description
Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber seal with colored aluminum seals Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood.
Reason for Recall
A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of the control after reconstitution, which could result in an out of specification result prior to the current reconstitution claim of 7 days. For this reason we suggest discontinuing use of the control set.
Distribution Pattern
Worldwide distribution: US (nationwide) including states of: PA, CA, KY, FL, NJ, DE, MI, MN,and IL; and countries of: United Arab Emirates, Austria, Italy, Israel, Greece, and Australia.
Lot / Code Information
Lot: 505801 Expiration date: 2015-11 catalog numbers: G7583-CTL 7-G7583-CTL-L1 7-G7583-CTL-L2 7-G7583-CTL-L3
Other Recalls from Pointe Scientific, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2764-2015 | Class III | Pointe Scientific autoHDL Reagent H7545 H754... | Mar 13, 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.