The Recall Desk
HighFDA (Devices)·Z-0082-2022·Announced 2021-10-20

Bio-Rad BioPlex 2200 ANA Screen Control lot incompatible with reagents

Bio-Rad Laboratories has recalled certain lots of BioPlex 2200 ANA Screen Control Sets due to incompatibility with older lots of ANA Screen Reagent Packs and Calibrator Sets, which may affect test accuracy.

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: Class II medical device recall of a diagnostic control set with potential to affect test accuracy. Qualifies as a risk-of-harm product without reported injuries per the severity rubric.

Plain-English summary

Bio-Rad Laboratories, Inc. is recalling BioPlex 2200 ANA Screen Control Sets due to incompatibility with older lot numbers of reagent packs and calibrator sets used on the BioPlex 2200 analyzer system.

New lots of the control set are incompatible with certain older lots of ANA Screen Reagent Packs and ANA Screen Calibrator Sets. This incompatibility may affect the accuracy or reliability of antinuclear antibody (ANA) screening tests performed with the system. No illnesses or injuries have been reported.

The affected control sets were distributed worldwide, including throughout the United States and internationally.

The recalled product

Product
BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101
Manufacturer
Bio-Rad Laboratories, Inc.
Category
Medical Device — In Vitro Diagnostic Control
Hazard
  • lot-incompatibility
  • diagnostic-accuracy-risk

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 (13)

  • REF: 663-1131
  • Lot: 51765
  • Expiration: 03/05/2021
  • and any subsequent lots incompatible with: REF: 665-1150
  • Lot-Expiration: 300884-11/30/2019
  • 300907-1/31/2020
  • 300928-3/31/2020
  • 300933-4/30/2020
  • and REF: 663-1101
  • Lot-Expiration: 50661-11/30/2019
  • 50726-3/11/2020
  • 50835-3/27/2020
  • 50858-5/1/2020

Distribution

Distributed nationwide across the United States.

Related recalls

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