Lower riskMedical device recall · FDA · Published November 1, 2019
Bio-Rad BioPlex 2200 ANA Screen Control Set Incompatible with Older Reagents
Bio-Rad recalls BioPlex 2200 ANA Screen Control Sets (REF: 663-1131) that are incompatible with older ANA reagent packs and calibrators. Affected units may cause inaccurate test results.
“Bio-Rad BioPlex 2200 ANA Screen Control Set Incompatible with Older Reagents.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66583-bio-rad-bioplex-2200-ana-screen-control-set-incompatible-with. Based on FDA recall #Z-0082-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0082-2022%22&limit=1).
The FDA announced on 2019-11-01 that Bio-Rad Laboratories, Inc. is recalling its BioPlex 2200 ANA Screen Control Set due to incompatibility with certain older ANA calibrators and reagent packs. The agency classified the recall as Class II.
How to tell if you have it
Brand: Bio-Rad
Product: BioPlex 2200 ANA Screen Control Set, REF: 663-1131
Lot: 51765, Expiration: 03/05/2021
Incompatible with REF: 665-1150, Lot-Expiration: 300884-11/30/2019, 300907-1/31/2020, 300928-3/31/2020, 300933-4/30/2020
Incompatible with REF: 663-1101, Lot-Expiration: 50661-11/30/2019, 50726-3/11/2020, 50835-3/27/2020, 50858-5/1/2020
The hazard
A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs, according to the FDA.
Context
GovInfoNow's records show Bio-Rad Laboratories, Inc. has 12 other recalls on record since 2018-04-02. Other recent recalls include a 2025-05-30 recall of the Bio-Rad Platelia Toxo IgM Kit due to false positive risks and a 2023-02-28 recall of the Bio-Rad BioPlex 220 for incorrect reagent packaging.
How to tell if you have this one
Check for BioPlex 2200 ANA Screen Control Sets with reference number 663-1131, lot number 51765 or later. Also look for older reagent packs (REF: 665-1150) and calibrators (REF: 663-1101) with specific expiration dates listed in the recall.
Brand
Bio-Rad
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Compatibility
Verify if your BioPlex 2200 ANA Screen Control Set (REF: 663-1131) is compatible with your reagent packs and calibrators by checking the lot numbers and expiration dates.
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 including in the states of CA, FL, NJ, IL, NE, TN, IN, TX, LA, WA, MI, MA, MN, OH, HI, MO, PA, CT, UT, SD, NY, AL, PR, OR, MD, KY, NC, AZ, SC, VA, WI, GA, IA, RI, AK, OK, KS, ND, MS, ME,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 3.9 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0082-2022 (November 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0082-2022 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.