Bio-Rad recalls BioPlex 2200 Syphilis Total & RPR Reagent Pack due to possible interference with COVID-19 vaccines. Affected units have specific lot numbers and catalog codes. No immediate action needed as the hazard is not active in normal use.
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
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📍Recalling firmBio-Rad Laboratories, Inc.6565 185th Ave Ne · Redmond, WA 98052-5039
✎ GovInfoNow plain-language explainer
Bio-Rad is recalling a syphilis testing reagent pack because it may interact with COVID-19 vaccines. This doesn't mean the test is unsafe, but it could affect results if someone has received a vaccine recently. The recall is for specific lot numbers and catalog codes. Read more at govinfonow.com/recall/61171-bio-rad-bioplex-2200-syphilis-reagent-pack-potential-covid-19.
“Bio-Rad BioPlex 2200 Syphilis Reagent Pack: Potential COVID-19 Vaccine Interference.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/61171-bio-rad-bioplex-2200-syphilis-reagent-pack-potential-covid-19. Based on FDA recall #Z-0806-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0806-2022%22&limit=1).
The FDA announced on Feb. 8, 2022, that Bio-Rad Laboratories Inc. voluntarily recalled its BioPlex 2200 Syphilis Total & RPR Reagent Pack due to potential COVID-19 vaccine interference and manufacturing stability issues. The agency classified the recall as Class II.
How to tell if you have it
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Catalog Number: 12000650
UPC: 03610520653012
Lot Numbers: 301336
The hazard
According to the FDA, the recall addresses concerns regarding COVID-19 vaccine interference with the RPR portion of the panel, alongside intermittent manufacturing challenges that prevent reagents from consistently meeting stability specifications.
Context
GovInfoNow's records show Bio-Rad Laboratories Inc. has 12 other recalls on record since April 2, 2018. Recent similar recalls include the Bio-Rad Platelia Toxo IgM Kit Recall dated May 30, 2025, and the Bio-Rad BioPlex 220 recall dated Feb. 28, 2023. Other recent recalls of similar products include the Biofire Defense FilmArray NGDS Warrior Panel Recall (July 16, 2026), the BioFire Respiratory Panel 2.1 Recall (Oct. 22, 2025), and the Medline IVS Blood Culture Kits Recall (June 12, 2026).
How to tell if you have this one
Check for catalog number 12000650 and lot numbers starting with 301336. The reagent pack is sold by Bio-Rad Laboratories, Inc. for syphilis testing.
Brand
Bio-Rad
Product
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
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 distribution in the 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, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of France, Germany, Italy, Spain, Saudi Arabia, and United Arab Emirates.
Recall number
Product, codes & lots
Quantity
Z-0806-2022
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack; Catalog Number: 12000650 UDI GTIN Code: 03610520653012 Lot Numbers: 301336
9,426 packs (U.S.)
Z-0807-2022
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL; Catalog Number: 12000651 UDI GTIN Code: 03610520652770 Lot Numbers: 53262
724 Calibrator sets (U.S.)
Based on the official FDA remedy
What to do — step by step
Check Your Reagent Pack
Verify the catalog number is 12000650 and lot number starts with 301336.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 41 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution U.S. Nationwide distribution in the 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, RI, SC, SD, TN, TX, UT, VA, WA,…” 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0806-2022 (February 8, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0806-2022 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 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.