Exact FDA event identifier

Event 89684

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: February 08, 2022
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

2 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 2

BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack

Z-0806-2022

Recall number: Z-0806-2022
Initiated: February 08, 2022
Classification: Class II
Status: Ongoing
Recalling firm: Bio-Rad Laboratories, Inc.
Quantity: 9,426 packs (U.S.)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

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

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

Code information

Catalog Number: 12000650 UDI GTIN Code: 03610520653012 Lot Numbers: 301336

Distribution pattern

Worldwide distribution U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of France, Germany, Italy, Spain, Saudi Arabia, and United Arab Emirates.

device · product 2 of 2

BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

Z-0807-2022

Recall number: Z-0807-2022
Initiated: February 08, 2022
Classification: Class II
Status: Ongoing
Recalling firm: Bio-Rad Laboratories, Inc.
Quantity: 724 Calibrator sets (U.S.)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

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

Code information

Catalog Number: 12000651 UDI GTIN Code: 03610520652770 Lot Numbers: 53262