The Recall Desk
HighFDA (Devices)·Z-0236-2022·Announced 2021-11-24

Syphilis Test Calibrator Recalled for False-Positive Reactivity Issues

Bio-Rad BioPlex 2200 Syphilis calibrator set (791 units, Lot 52953) is recalled due to elevated test reactivity that does not confirm with treponemal tests and potential early shelf-life failure causing measurement bias.

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 an FDA Class II medical device where diagnostic accuracy directly affects patient test results. Elevated RPR reactivity leading to false-positive syphilis results constitutes a risk of harm to patient care decisions, though no illnesses or injuries have been reported. The recall is based on confirmed measurement defects rather than a low-risk precautionary measure.

Plain-English summary

Bio-Rad Laboratories is recalling 791 units of the BioPlex 2200 Syphilis Total & RPR Calibrator Set (Catalog Number 12000651, Lot 52953). The product is used to calibrate syphilis testing equipment in clinical laboratories.

The recall was issued due to two identified issues: customer complaints reported elevated Rapid Plasma Reagin (RPR) reactivity that does not confirm with treponemal antibody tests, suggesting false-positive results. Additionally, routine stability monitoring detected an increase in mean bias above specification, indicating potential early shelf-life failure that could cause elevated RPR reactivity.

The affected lot was distributed worldwide, including all 50 U.S. states and Puerto Rico, as well as France, Germany, Israel, Italy, Russian Federation, South Africa, Spain, and Taiwan. Laboratories that received this calibrator set should discontinue use and contact Bio-Rad Laboratories for replacement or further instructions.

The recalled product

Product
BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
Manufacturer
Bio-Rad Laboratories, Inc.
Category
Medical Device — Laboratory Diagnostic
Hazard
  • false-positive
  • measurement-bias

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: 12000651 UDI Code: 03610520652770 Lot Number: 52953

Distribution

Distributed nationwide across the United States.

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