The Recall Desk
HighFDA (Devices)·Z-0235-2022·Announced 2021-11-24

Syphilis Test Reagent Pack Recalled Due to False Positive Results

Bio-Rad is recalling 11,610 units of BioPlex 2200 syphilis test reagent packs because they can produce false positive results that don't confirm with follow-up tests, due to elevated reactivity and shelf-life issues.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device (diagnostic test) where false positive results could lead to incorrect diagnoses, but no reported illnesses, injuries, or hospitalizations are documented in the source text.

Plain-English summary

Bio-Rad Laboratories is recalling 11,610 units of BioPlex 2200 syphilis test reagent pack (Catalog 12000650, Lot 301210) distributed in the United States and internationally to France, Germany, Israel, Italy, Russia, South Africa, Spain, and Taiwan.

The recall addresses two issues. Bio-Rad received customer complaints about greater-than-expected Rapid Plasma Reagin (RPR) reactivity that did not confirm with treponemal antibody tests, indicating false positive results. Additionally, during routine stability monitoring, Bio-Rad detected an increase in mean bias above specification, which can cause elevated RPR reactivity potentially due to early shelf-life failure.

The BioPlex 2200 is a diagnostic test kit used by laboratories to detect syphilis antibodies in blood samples. Affected users should immediately stop using this lot and contact Bio-Rad or the FDA for guidance on verifying previous results and appropriate follow-up procedures.

The recalled product

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 ti
Manufacturer
Bio-Rad Laboratories, Inc.
Category
Medical Device — Diagnostic Test Kit
Hazard
  • false-positive-results
  • shelf-life-failure

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 (1)

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

Distribution

Distributed nationwide across the United States.

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