FDA Device recall Z-0807-2022
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
- FDA Device
- Class II
- ongoing
- Published 2022-03-23
On 2022-03-23 the FDA classified a Class II recall of BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL by Bio Rad Laboratories, citing due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challen….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0807-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-08 |
| Published | 2022-03-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bio Rad Laboratories |
| Distribution | US |
Product
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
Reason
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
Identifiers
| code_info | Catalog Number: 12000651 UDI GTIN Code: 03610520652770 Lot Numbers: 53262 |
|---|
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-0807-2022%22
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