BioPlex 2200 6652050Recalls & reported problems
Bio-Rad Laboratories, Inc. · APLS IgM Reagent Pack · Class 2
All models of BioPlex 2200 (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847865000666), received between Mar 8, 2023 and Mar 8, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Feb 28, 2023Class IIOpen, Classified
APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
Z-1572-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- False Negative Result1
- False Positive Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2023False Negative Result; False Positive Result; False Negative Result; False Positive Result
BIO-RAD LABORATORIES RECEIVED A CUSTOMER COMPLAINT REGARDING INTERMITTENT QC FAILURE WHEN RUNNING BIOPLEX 2200 APLS IGM REAGENT PACKS, LOT NO. 301538. BIO-RAD LABORATORIES DETERMINED THAT A SMALL PERCENTAGE OF THIS REAGENT PACK LOT WAS PACKAGED WITH THE INCORRECT CONJUGATE. THERE WERE NO REPORTED ADVERSE EVENT WITH THIS LOT. HOWEVER, THE USE OF REAGENT PACKS CONTAINING THE INCORRECT CONJUGATE MAY LEAD TO AN INCREASE OF FALSE POSITIVE AND FALSE NEGATIVE RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16507633 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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