Bio-Rad BioPlex 220: Incorrect Reagent May Cause False Test Results
Bio-Rad recalls BioPlex 2200 APLS IgM reagent kits with incorrect conjugate that may cause false positive or negative test results. Affected kits have specific lot codes and UDI-DI numbers.
Lower-risk recall
APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
Contact the company
What happened, in plain English
Bio-Rad is recalling APLS IgM reagent packs that were packaged with the wrong chemical, which could cause lab tests to show false positive or false negative results. This means test results might be inaccurate, potentially leading to incorrect health decisions. Read more at govinfonow.com/recall/58841-bio-rad-bioplex-220-incorrect-reagent-may-cause-false-test.
Source Summary by GovInfoNow · govinfonow.com/recall/58841-bio-rad-bioplex-220-incorrect-reagent-may-cause-false-test · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1572-2023
Cite this page
“Bio-Rad BioPlex 220: Incorrect Reagent May Cause False Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58841-bio-rad-bioplex-220-incorrect-reagent-may-cause-false-test. Based on FDA recall #Z-1572-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1572-2023%22&limit=1).
Why it’s dangerous
The reagent kits contain the incorrect chemical conjugate, which can cause lab tests to give false positive or false negative results. This means test results might not match the actual condition being checked, leading to potential misdiagnosis.
Who’s affected
Lab technicians and healthcare providers who use these reagent kits for blood tests. Those who rely on accurate test results for diagnosis are most at risk.
How to tell if you have this one
Check for lot code 301538 or UDI-DI number (00)847865000666 on the BioPlex 2200 APLS IgM reagent packs. These kits were sold by Bio-Rad Laboratories, Inc.
- Brand
Bio-Rad- Category
Medical device
What to do — step by step
Check Kit Details
Look for lot code 301538 or UDI-DI number (00)847865000666 on the BioPlex 2200 APLS IgM reagent packs.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 27 states.
FDA distribution: “US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, HI, IL, IN, KS, KY, LA, MI, MO, NC, ND, NE, NJ, NM, NY, OH, OK, PR,SC, TN, TX, UT, VT.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Connecticut, Florida, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Vermont.
Recall timeline
FDA published this recall 3 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.
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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-1572-2023 (February 28, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1572-2023 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.