Z-0082-2022Class II

BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF...

Name: Z-0082-2022 BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF...
Creator: Bio-Rad Laboratories, Inc.
Published: 2019-11-01
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2019-11-01 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories, Inc. began a recall of 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... on 2019-11-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0082-2022
Classification: Class II
Status: Terminated
Initiated: 2019-11-01
Posted: 2021-10-08
Terminated: 2023-09-27
Recalling firm: Bio-Rad Laboratories Inc.
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
Product code: LKJ Antinuclear Antibody, Antigen, Control
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 11/01/2019, ANA Screen Lot Matching-Compatibility Notice, were mailed to customers. Customers were advised of the following: If you have received the new control material, please ensure that your laboratory is using one of the newer lot numbers of BioPlex ANA calibrators and ANA reagents. Should you have any of the older BioPlex ANA reagent packs and calibrator sets listed below in ITALICS remaining in your inventory or if you have used these lots in combination with the new control, please contact your local Technical Support center. The following telephone number was provided: 510-724-7000.
Quantity in commerce: 206
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0082-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0082-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-20	2021-10-08

Product code LKJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)