Unrated Medical device recall · FDA · Published September 17, 2021

Bio-Rad BioPlex 2200 Syphilis Calibrator Set Recall: False Positive RPR Results Risk

Bio-Rad recalls BioPlex 2200 Syphilis Total & RPR Calibrator Set (12000651) due to potential false positive RPR results from COVID vaccinations and stability issues. Affected units may show incorrect syphilis test results.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0236-2022Medical device Bio-Rad ›

Recall notice

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.

Take action

Contact the company

Recalling firmBio-Rad Laboratories, Inc.6565 185th Ave Ne · Redmond, WA 98052-5039

✎ GovInfoNow plain-language explainer

Bio-Rad is recalling its BioPlex 2200 Syphilis Total & RPR Calibrator Set (model 12000651) because it may produce false positive results for syphilis tests, especially after COVID vaccinations. This could lead to incorrect diagnoses if used in testing. Read more at govinfonow.com/recall/61796-bio-rad-bioplex-2200-syphilis-calibrator-set-recall-false-positive.

Source Summary by GovInfoNow · govinfonow.com/recall/61796-bio-rad-bioplex-2200-syphilis-calibrator-set-recall-false-positive · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0236-2022

Cite this page

“Bio-Rad BioPlex 2200 Syphilis Calibrator Set Recall: False Positive RPR Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61796-bio-rad-bioplex-2200-syphilis-calibrator-set-recall-false-positive. Based on FDA recall #Z-0236-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0236-2022%22&limit=1).

The FDA announced on 2021-09-17 that Bio-Rad Laboratories, Inc. is recalling the BIO-RAD BioPlex 2200 Syphilis Total & RPR Calibrator Set due to potential false reactive results and elevated bias. The agency classified the recall as Class II.

How to tell if you have it

Brand: Bio-Rad
Product: BIO-RAD BioPlex 2200 Syphilis Total & RPR Calibrator Set CAL
Catalog Number: 12000651
Lot Number: 52953
Units affected: 791

The hazard

The calibrator set may cause greater than expected Rapid Plasma Reagin (RPR) reactivity that does not confirm with treponemal antibody tests, potentially due to a positive correlation between mass COVID vaccinations and false reactive RPR results. Additionally, an increase in mean bias above specification was observed during routine stability monitoring, which can cause elevated RPR reactivity potentially due to early shelf-life failure.

Context

GovInfoNow's records show Bio-Rad Laboratories, Inc. has 12 other recalls on record since 2018-04-02. Other recent recalls of similar products include the Bio-Rad Platelia Toxo IgM Kit Recall (2025-05-30), the Bio-Rad BioPlex 220: Incorrect Reagent May Cause False Test Results (2023-02-28), and the Bio-Rad BioPlex 2200 Anti-CCP Calibrator Set Recall (2023-02-21). Other recent recalls of similar products include the Meridian Bioscience Revogene C. difficile Test Recall (2025-12-05), the BioFire Joint Infection Panel Recall (2026-04-22), and the Biomerieux VITEK 2 AST-N447 Kit Recall (2026-06-04).

How to tell if you have this one

Check for the model number 12000651 on the calibrator set. The product was sold with UDI code 03610520652770 and lot number 52953.

Brand
Bio-Rad
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
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.

Recall number	Product, codes & lots	Quantity
Z-0235-2022	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; Catalog Number: 12000650 UDI Code: 03610520653012 Lot Number: 301210	11,610 units
Z-0236-2022	BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.; Catalog Number: 12000651 UDI Code: 03610520652770 Lot Number: 52953	791 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the model number 12000651 and UDI code 03610520652770 on the calibrator set.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 40 states.

FDA distribution: “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;…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

Sep 17, 2021Firm started the recall
Nov 16, 2021FDA classified it Class II
Nov 24, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61796-bio-rad-bioplex-2200-syphilis-calibrator-set-recall-false-positive">Bio-Rad BioPlex 2200 Syphilis Calibrator Set Recall: False Positive RPR Results Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0236-2022 (September 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0236-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.