Bio-Rad BioPlex 2200 Syphilis Kit Has Increased RPR Reactivity - Recall
Bio-Rad recalls BioPlex 2200 Syphilis Total & RPR kit due to potential increased RPR reactivity in specific lots. Affected kits may produce inaccurate results for syphilis testing.
Lower-risk recall
The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
Contact the company
What happened, in plain English
Bio-Rad is recalling certain lots of their BioPlex 2200 Syphilis Total & RPR kit because the RPR reactivity level is higher than expected. This could lead to inaccurate syphilis test results, which is important for proper diagnosis and treatment. Read more at govinfonow.com/recall/65348-bio-rad-bioplex-2200-syphilis-kit-has-increased-rpr-reactivity.
Source Summary by GovInfoNow · govinfonow.com/recall/65348-bio-rad-bioplex-2200-syphilis-kit-has-increased-rpr-reactivity · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2982-2020
Cite this page
“Bio-Rad BioPlex 2200 Syphilis Kit Has Increased RPR Reactivity - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65348-bio-rad-bioplex-2200-syphilis-kit-has-increased-rpr-reactivity. Based on FDA recall #Z-2982-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2982-2020%22&limit=1).
Why it’s dangerous
The kit's RPR reactivity level is higher than intended, which can cause false positive results in syphilis testing. This means the test might incorrectly indicate that someone has syphilis when they do not, or vice versa.
Who’s affected
People who use the BioPlex 2200 Syphilis Total & RPR kit for syphilis testing are affected. Those who have recently used the kit with the specific UDI 03610520653012 and lot numbers 301142 or later are most at risk.
How to tell if you have this one
Check the kit's unique device identifier (UDI) 03610520653012 and lot numbers. The affected kits will have lot numbers starting from 301142 or later.
- Brand
Bio-Rad- Category
Medical device
What to do — step by step
Check Kit Details
Look for the unique device identifier (UDI) 03610520653012 and lot numbers starting from 301142 or later on the kit.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 41 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, 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, Maryland, 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, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this kit?
Check the kit's UDI and lot number. If it matches the affected details, you should stop using it and contact Bio-Rad for further instructions.
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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-2982-2020 (April 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2982-2020 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.