Bio-Rad Laboratories, Inc.: BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma

Recall number

Z-0235-2022

Recalling firm

Bio-Rad Laboratories, Inc.

Product

BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma

Status

Open, Classified

Initiated

2021-09-17

Posted

not on file

Terminated

not on file

Reason

Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.

Root cause

Nonconforming Material/Component

Action

On 09/17/2021, the Recalling Firm sent an "URGENT PRODUCT NOTIFICATION" Letter to customer via overnight FedEx informing them of two issues their Syphilis Total and RPR (Rapid Plasma Reagin) kits: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure. Customer are instructed to: -Immediately discontinue use and dispose of any unused product of reagent packs and calibrator set according to local waste management procedures. -Complete the customer response form and return it to their local Recalling Firm Technical Support, or return this form to Techsupport.ussd@bio-rad.com or the Toll-Free Fax 1-888-228-0688 within 10 days of receiving this notice.. -If the affected products have been further distributed or transferred, notify those customers of the field action. For additional questions, contact local Bio-Rad Technical Support.

Quantity

11,610 units

Distribution

Worldwide Distribution: U.S.(nationwide) including 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, SC, SD, TN, TX, UT, VA, WA, WI, and WV; O.U.S.(foreign) countries of: France, Germany, Israel, Italy, Russian Federation, South Africa, Spain, and Taiwan.

Lot, serial or model codes

Catalog Number: 12000650 UDI Code: 03610520653012 Lot Number: 301210

510(k) numbers

["K170413"]

PMA numbers

not on file

Product code

LIP

Firm FEI

3008272466

Firm city

Redmond

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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