Reported Sep 30, 2020 · Ongoing
BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage:…
Bio-Rad Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bio-Rad Laboratories, Inc. · 6565 185th Ave Ne · Redmond, WA · 98052-5039
Is this the product you have?
- BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay
- Treponema pallidumUDI:03610520653012 -
- Product Usageintended 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
- Lot codes and dates
- 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 1ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM (LIP)
- Product Code 2ANTIGENS, NONTREPONEMAL, ALL (GMQ)
- Product Code 3CALIBRATOR, SECONDARY (JIT)
- Product Code 4SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX)
- Amount recalled
- 12000 kits
Where it was sold
Why it was recalled
The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
This product could cause temporary or reversible health problems — stop using it.
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