The Recall Desk
HighFDA (Devices)·Z-0806-2022·Announced 2022-03-23

Syphilis Test Reagent Pack Recalled for Vaccine Interference and Manufacturing Defects

Bio-Rad's BioPlex 2200 Syphilis Test Reagent Pack is being recalled due to concerns that COVID-19 vaccines may interfere with test results, and due to manufacturing defects affecting reagent stability.

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 recall of a diagnostic medical device with no reported illnesses or injuries. The hazard involves potential vaccine interference with test results and manufacturing stability issues that could affect test accuracy. Under the severity rubric, this constitutes a risk-of-harm product where injury has not yet been reported, warranting a High severity score.

Plain-English summary

Bio-Rad Laboratories, Inc. is recalling the BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack. This medical device is used in clinical laboratories to perform syphilis testing, including total syphilis and RPR (rapid plasma reagin) testing.

The recall was issued due to two identified concerns. First, there is potential for COVID-19 vaccine interference specifically with the RPR portion of the syphilis test panel, which could affect test accuracy. Second, Bio-Rad identified intermittent manufacturing challenges in producing RPR reagents that consistently meet FDA stability specifications required for safe and effective use.

Approximately 9,426 packs have been distributed in the United States across all 50 states and Puerto Rico, and internationally to France, Germany, Italy, Spain, Saudi Arabia, and the United Arab Emirates. Lot Number 301336 is affected.

Healthcare facilities and laboratories using this product should discontinue use immediately and contact Bio-Rad for replacement supplies or further guidance.

The recalled product

Product
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Manufacturer
Bio-Rad Laboratories, Inc.
Category
Medical Device — Diagnostic Reagent
Hazard
  • vaccine-interference
  • manufacturing-defect

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 GTIN Code: 03610520653012 Lot Numbers: 301336

Distribution

Distributed nationwide across the United States.

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