Bio-Rad Recalls BioPlex 2200 Syphilis Assay Due to Increased Reactivity
Bio-Rad is recalling BioPlex 2200 Syphilis Total & RPR kits because of increased RPR reactivity levels in the kit material.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bio-Rad Laboratories, Inc. is recalling the BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay. The recall is due to increased levels of RPR reactivity in the kit material, specifically material number 12000650.
The affected product is 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. The recall involves 12,000 kits. 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).
Distribution was worldwide, including the United States (nationwide), Canada, Switzerland, France, Italy, Spain, Romania, and the United Kingdom. Healthcare facilities and laboratories should stop using the affected lots and contact Bio-Rad Laboratories for instructions on returning the product.
The recalled product
- 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…
- Manufacturer
- Bio-Rad Laboratories, Inc.
- Affected units
- 12,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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)
Distribution
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