Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751

FDA Device Recall #Z-1906-2021 — Class II — May 7, 2021

Recall Summary

Recall Number Z-1906-2021
Classification Class II — Moderate risk
Date Initiated May 7, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Beckman Coulter Inc.
Location Brea, CA
Product Type Devices
Quantity 3,843 units

Product Description

Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751

Reason for Recall

SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.

Distribution Pattern

US: Alabama, Alaska, Arizona, Arkansas, California, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West Virginia, Wisconsin, Wyoming, OUS: Andorra, Austria, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Jordan, Poland, Portugal, San Marino, Slovakia, Slovenia, Spain, United Arab Emirates

Lot / Code Information

All Lots

Other Recalls from Beckman Coulter Inc.

Recall # Classification Product Date
Z-0541-2026 Class II DxFLEX Flow Cytometer Catalog Number C78500 UD... Sep 22, 2025
Z-0441-2026 Class II SYNCHRON Systems Direct LDL Cholesterol (LDLD) ... Sep 17, 2025
Z-0071-2026 Class II SYNCHRON Systems Phosphorus (PHOSm) Reagent RE... Sep 3, 2025
Z-2573-2025 Class II UniCel DxH 690T COULTER Cellular Analysis Syste... Aug 13, 2025
Z-2574-2025 Class II UniCel DxH 800 COULTER Cellular Analysis System... Aug 13, 2025

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.