Z-2982-2020Class II

BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 -

Name: Z-2982-2020 BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 -
Creator: Bio-Rad Laboratories, Inc.
Published: 2020-04-21
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2020-04-21 / Open, Classified

FDA source

Bio-Rad Laboratories, Inc. began a recall of BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection... on 2020-04-21. FDA classified it as Class II and gives the reason as "The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2982-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-04-21
Posted: 2020-09-18
Recalling firm: Bio-Rad Laboratories Inc.
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.
Product code: LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Reason for recall: The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
FDA root cause: Unknown/Undetermined by firm
Action: Consignees that have purchased active lots of the BioPlex 2200 Syphilis Total and RPR kit have been notified of the Field Correction via a customer letter sent via Fed Ex overnight ; date issued 04/21/2020. The communication was to inform that the RPR portion of the BioPlex 2200 Syphilis Total & RPR assay will be temporarily disabled. The RPR assay will be disabled beginning with reagent lot 301142 of the BioPlex 2200 Syphilis Total & RPR assay (Catalog No. 12000650, UDI 03610520653012) and calibrator lot 52216 (Catalog No. 12000651, UDI 03610520652770). The reporting of the RPR assay results will be disabled by the installation of a new assay protocol file (APF). The communication includes that there are no modifications to the chemistry of the assay reagents or processing of the assay by the BioPlex 2200 System. The RPR assay will remain disabled until further notice. Consignees are asked to complete and return the Customer Response form (fax: 1-888-228-0688/email: [email protected]) to confirm receipt of the communication and to receive instructions for installation of the new APF; return the form within 10 days of receiving the notice. Additionally, consignees are asked to contact their local technical support if there are any questions about the notification.
Quantity in commerce: 12000 kits
Distribution: 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).
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2982-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2982-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-30	2020-09-18

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)