Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to ...
FDA Device Recall #Z-0937-2014 — Class II — December 19, 2013
Recall Summary
| Recall Number | Z-0937-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 19, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ITC-Nexus Dx |
| Location | Edison, NJ |
| Product Type | Devices |
| Quantity | 25,965 curvettes (7,425 cuvettes US; 18,540 cuvettes OUS) |
Product Description
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.
Reason for Recall
ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.
Lot / Code Information
E3JCC013-P1 - exp 2014-05 E3JCC014-P2 - exp - 2014-05 F3JCC015-P3 - exp -2014-06 F3JCC016 - exp - 2014-06 H3JCC017 - exp - 2014-08
Other Recalls from ITC-Nexus Dx
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2088-2014 | Class II | Hemochron Jr. Whole Blood Microcoagulation Syst... | Jun 20, 2014 |
| Z-0137-2014 | Class II | Surgicutt fully automated incision making devic... | Aug 22, 2013 |
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.