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

Class I - Dangerous

🏥 Medical Devices Recalled: November 1, 2019 Bio-Rad Laboratories Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Bio-Rad Laboratories, Inc.
Reason for Recall:: A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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