BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syph...

FDA Device Recall #Z-0235-2022 — Class II — September 17, 2021

Recall Summary

Recall Number Z-0235-2022
Classification Class II — Moderate risk
Date Initiated September 17, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bio-Rad Laboratories, Inc.
Location Redmond, WA
Product Type Devices
Quantity 11,610 units

Product Description

BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma

Reason for Recall

Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.

Distribution Pattern

Worldwide Distribution: U.S.(nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, and WV; O.U.S.(foreign) countries of: France, Germany, Israel, Italy, Russian Federation, South Africa, Spain, and Taiwan.

Lot / Code Information

Catalog Number: 12000650 UDI Code: 03610520653012 Lot Number: 301210

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Z-1377-2023 Class II BioPlex 2200, Anti-CCP Reagent Pack, REF 665-32... Feb 21, 2023
Z-1378-2023 Class II BioPlex 2200, Anti-CCP Calibrator Set, REF 663-... Feb 21, 2023
Z-0342-2023 Class II CMV IgM EIA, in vitro diagnostic. Oct 19, 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.