Z-0235-2022Class II

BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total &...

Name: Z-0235-2022 BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total &...
Creator: Bio-Rad Laboratories, Inc.
Published: 2021-09-17
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2021-09-17 / Open, Classified / root cause: manufacturing process

FDA source

Bio-Rad Laboratories, Inc. began a recall of 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... on 2021-09-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0235-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-17
Posted: 2021-11-16
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
Product code: LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected] 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 in commerce: 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.
Product codes and lots: Catalog Number: 12000650 UDI Code: 03610520653012 Lot Number: 301210

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0235-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0235-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-24	2021-11-16
Z-0236-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-24	2021-11-16

Product code LIP

K170413Class IIBioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetBio-Rad Laboratories / cleared 2017-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)