FDA Device recall Z-2982-2020
BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qu…
- FDA Device
- Class II
- ongoing
- Published 2020-09-30
On 2020-09-30 the FDA classified a Class II recall of BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qu… by Bio Rad Laboratories, citing the increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2982-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-04-21 |
| Published | 2020-09-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bio Rad Laboratories |
| Distribution | US |
Product
BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.
Reason
The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
Identifiers
| code_info | The RPR assay will be disabled beginning with reagent lot 301142 and future manufactured lots of the BioPlex 2200 Syphi…The RPR assay will be disabled beginning with reagent lot 301142 and future manufactured lots of the BioPlex 2200 Syphilis Total & RPR assay (Catalog No. 12000650, UDI 03610520653012) and calibrator lot 52216 (Catalog No. 12000651, UDI 03610520652770). Product Code 1: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM (LIP), Product Code 2: ANTIGENS, NONTREPONEMAL, ALL (GMQ), Product Code 3: CALIBRATOR, SECONDARY (JIT), Product Code 4:SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2982-2020%22
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