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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 206
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
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