FDA Device recall Z-1572-2023
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
- FDA Device
- Class II
- ongoing
- Published 2023-05-17
On 2023-05-17 the FDA classified a Class II recall of BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack by Bio Rad Laboratories, citing APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1572-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-28 |
| Published | 2023-05-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bio Rad Laboratories |
| Distribution | US |
Product
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Reason
APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
Identifiers
| code_info | Lot Code: 301538; UDI-DI: (00)847865000666 |
|---|
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-1572-2023%22
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