BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human...
FDA Device Recall #Z-1227-2023 — Class II — February 1, 2023
Recall Summary
| Recall Number | Z-1227-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 1, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Aniara Diagnostica LLC |
| Location | West Chester, OH |
| Product Type | Devices |
| Quantity | 2 units |
Product Description
BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac (Agkistrodom Contortrix), an enzyme extracted from snake venom. Activated protein C hydrolysis the chromogenic substrate (SaPC-21) which release para-nitroaniline (pNA). The amount of pNA released (measured by absorbance at 405 nm) is directly proportional to the concentration of Protein C in the specimen.
Reason for Recall
New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which changed classification and has become hazardous according to the CLP regulation ((EC) No 1272/2008) is suspected of damaging fertility
Distribution Pattern
US Nationwide distribution in the state of NC.
Lot / Code Information
UDI-DI: 366353700063BD Lot FA083327 (And all future lots)
Other Recalls from Aniara Diagnostica LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1743-2022 | Class III | BIOPHEN UFH Control Plasma | Jun 28, 2022 |
| Z-2346-2019 | Class II | ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No... | Jul 19, 2019 |
| Z-2347-2019 | Class II | ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model ... | Jul 19, 2019 |
| Z-1189-2019 | Class III | BIOPHEN UFH Control C1, REF 224101 | Mar 19, 2019 |
| Z-1190-2019 | Class III | BIOPHEN LMWH Control C4, REF 224201 | Mar 19, 2019 |
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.