Reported Oct 20, 2021 · Terminated

BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150;…

Bio-Rad Laboratories, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bio-Rad Laboratories, Inc. · 6565 185th Ave Ne · Redmond, WA · 98052-5039

Is this the product you have?

  • BioPlex 2200 ANA Screen Control Set
  • REF663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits
  • REF665-1150; and ANA Screen Calibrator Sets
  • REF663-1101
Lot codes and dates

4 of 4 products

Products covered by this recall
Model / numberProduct as published
663-1131
Lot: 51765, Expiration: 03/05/2021, and any subsequent lots incompatible with
665-1150Lot-Expiration: 300884-11/30/2019, 300907-1/31/2020, 300928-3/31/2020, 300933-4/30/2020; and
663-1101Lot-Expiration: 50661-11/30/2019, 50726-3/11/2020, 50835-3/27/2020, 50858-5/1/2020
Amount recalled
206

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 27, 2023 · Data as of Sep 19, 6:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.