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BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD

FDA Device Recall #Z-1378-2023 — Class II — February 21, 2023

Recall Summary

Recall Number Z-1378-2023
Classification Class II — Moderate risk
Date Initiated February 21, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bio-Rad Laboratories, Inc.
Location Redmond, WA
Product Type Devices
Quantity 225 units

Product Description

BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD

Reason for Recall

Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8  96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1  98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8  96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1  98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8  96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1  98.8%). The reduction in specificity may lead to an increase in the number of false positives.There is no performance issue with the calibrator lot# 53727. They are included in the recall only because the calibrators are lot matched to the impacted reagent pack.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden.

Lot / Code Information

Lot # 53727; UDI GTIN: 00847865000819

Other Recalls from Bio-Rad Laboratories, Inc.

Recall # Classification Product Date
Z-2515-2025 Class II Platelia Toxo IgM Catalog Number 26211 UDI Cod... May 30, 2025
Z-1572-2023 Class II BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS ... Feb 28, 2023
Z-1377-2023 Class II BioPlex 2200, Anti-CCP Reagent Pack, REF 665-32... Feb 21, 2023
Z-0342-2023 Class II CMV IgM EIA, in vitro diagnostic. Oct 19, 2022
Z-1096-2022 Class II BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack Apr 14, 2022

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.

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