Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85636

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 21, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Bio-Rad Laboratories, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2982-2020
Recall number
Z-2982-2020
Initiated
April 21, 2020
Classification
Class II
Status
Ongoing
Quantity
12000 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.

Code information

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).

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TX, UT, VA, WA, WI, and WV. The countries of Canada (CA), Switzerland (CH), France (FR), Italy (IT), Spain (ES), and Romania (RO), and United Kingdom (GB).