The Recall Desk
HighFDA (Devices)·Z-0807-2022·Announced 2022-03-23

BioPlex 2200 Syphilis Calibrator Set Recall Due to Vaccine Interference and Reagent Stability Issues

Bio-Rad Laboratories is recalling 724 BioPlex 2200 Syphilis Calibrator sets due to COVID-19 vaccine interference concerns and manufacturing problems with reagent stability. The recalled lots were distributed nationwide in the U.S. and internationally.

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 Class II recall of a clinical laboratory calibration product with potential to affect test accuracy due to COVID-19 vaccine interference and manufacturing stability issues. No reported illnesses, injuries, or confirmed false results are documented, meeting the criterion for Score 3: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Bio-Rad Laboratories, Inc. is recalling 724 BioPlex 2200 Syphilis Total & RPR Calibrator Sets (Lot 53262), which are used in clinical laboratories to calibrate automated equipment for syphilis testing.

The recall is due to concerns related to COVID-19 vaccine interference with the RPR (Rapid Plasma Reagin) portion of the test panel. Additionally, Bio-Rad identified intermittent manufacturing challenges in producing RPR calibrator reagents that consistently meet stability specifications. These issues could affect the accuracy of syphilis test results.

The recalled calibrator sets were distributed nationwide in the United States across 40 states and Puerto Rico. International distribution included France, Germany, Italy, Spain, Saudi Arabia, and the United Arab Emirates.

The recalled product

Product
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
Manufacturer
Bio-Rad Laboratories, Inc.
Category
Medical Device — Laboratory Calibrator
Hazard
  • vaccine-interference
  • reagent-instability
  • test-inaccuracy

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 GTIN Code: 03610520652770 Lot Numbers: 53262

Distribution

Distributed nationwide across the United States.

Related recalls

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