FDA Device recall Z-1096-2022
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
- FDA Device
- Class II
- ongoing
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class II recall of BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack by Bio Rad Laboratories, citing performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1096-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-14 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bio Rad Laboratories |
| Distribution | US |
Product
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Reason
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
Identifiers
| code_info | Model/Catalog Number: 12000670 UDI-DI (GTIN) Code: 03610520992715 Lot Number: 301388 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1096-2022%22
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