Class II — Bio-Rad Laboratories, Inc.
| Recalling firm | Bio-Rad Laboratories (Bio-Rad Services France) |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results. |
| Product | BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack |
| Quantity | 932 Reagent Packs |
| 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. |
| Initiated | 2023-02-28 |
| Classified | 2023-05-10 |
| Recall number | Z-1572-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bio-Rad Laboratories, Inc. (Z-1572-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91889/
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