is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG ...

FDA Device Recall #Z-2921-2018 — Class III — October 21, 2016

Recall Summary

Recall Number Z-2921-2018
Classification Class III — Low risk
Date Initiated October 21, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Euro Diagnostica AB
Location Malmo
Product Type Devices
Quantity 6

Product Description

is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders.

Reason for Recall

Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

Distribution Pattern

MN

Lot / Code Information

Lot #'s: TS 2819 (kit) and TS 2841 (PC)

Other Recalls from Euro Diagnostica AB

Recall # Classification Product Date
Z-2627-2017 Class III DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIA... May 22, 2017
Z-0306-2018 Class II Euro Diagnostica DIASTAT ANA (anti-nuclear anti... Feb 14, 2017
Z-2919-2018 Class III is a quantitative/qualitative enzyme-linked imm... Oct 21, 2016
Z-2920-2018 Class III is a quantitative/qualitative enzyme-linked imm... Oct 21, 2016
Z-2922-2018 Class III is a qualitative indirect enzyme immunoassay en... Oct 21, 2016

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.