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Recall Observatory FDA recall evidence

Device 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

Z-0082-2022

November 01, 2019

Class II

Product summary

Firm
Bio-Rad Laboratories, Inc.
Event
Event 88652
Status
Terminated
Classification
Class II
Quantity
206
Official record key
device-enforcement:Z-0082-2022

Official wording

Reason: 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.

Code information: 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 pattern: Worldwide distribution - U.S Nationwide distribution including in the states of CA, FL, NJ, IL, NE, TN, IN, TX, LA, WA, MI, MA, MN, OH, HI, MO, PA, CT, UT, SD, NY, AL, PR, OR, MD, KY, NC, AZ, SC, VA, WI, GA, IA, RI, AK, OK, KS, ND, MS, ME, NM, AR and the countries of ES, AE, DE, FR, KR, CN, TW, JP, IL, SG, AU, NZ, HK, IT, CA, PT, GB, NO, CZ, SE, CH, UA, RU, BE, DK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.