Food, drugs, devices › Bio-Rad Laboratories, Inc.
Device recall: BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Bio-Rad Laboratories, Inc. (Redmond, WA) initiated this device recall on 14 Apr 2022; FDA lists 1 product record under event 90026, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Bio-Rad Laboratories, Inc. has 20 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Bio-Rad Laboratories, Inc., Redmond, WA.
Reason for recall
"Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack."
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1096-2022 | BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack | 348 units | Class II | Ongoing | 25 May 2022 |
Context
Other enforcement events for Bio-Rad Laboratories, Inc.
All 20 events for Bio-Rad Laboratories, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.