“Bio-Rad BioPlex 2200 REF 12000670 Reagent Pack: Variable CMV IgM Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60807-bio-rad-bioplex-2200-ref-12000670-reagent-pack-variable-cmv. Based on FDA recall #Z-1096-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1096-2022%22&limit=1).
The FDA announced on April 14, 2022, that Bio-Rad Laboratories is recalling the BioPlex 2200 ToRC IgM Reagent Pack due to performance concerns for the CMV IgM analyte. The agency stated the reagent may demonstrate variable elevated background depending on handling.
The reagent pack has performance concerns for the CMV IgM analyte. The FDA said the analyte demonstrated variable elevated background depending on the handling of the reagent pack.
Context
GovInfoNow's records show Bio-Rad Laboratories has had 12 other recalls since April 2, 2018. On May 30, 2025, the company recalled the Bio-Rad Platelia Toxo IgM Kit due to false positive risks. A February 28, 2023 recall involved incorrect reagents in Bio-Rad BioPlex 220 kits causing false test results. Other recent recalls of similar products include the Biofire Defense FilmArray NGDS Warrior Panel (July 16, 2026).
How to tell if you have this one
Check for the model number 12000670 on the reagent pack. The lot number 301388 is associated with this recall. The reagent is used for CMV IgM testing in laboratory settings.
Brand
Bio-Rad
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Reagent Pack
Verify the model number 12000670 and lot number 301388 on the reagent pack.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 14 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA, FL, HI, IA, IL, MI, MN, NE, NY, TN, TX, and WA. The countries of Czech Republic, France, Germany, and Italy.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Florida, Hawaii, Illinois, Iowa, Michigan, Minnesota, Nebraska, New York, Tennessee, Texas, Washington.
Recall timeline
FDA published this recall 41 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-1096-2022 (April 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1096-2022 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.