# FDA recall Z-0082-2022

> **Bio-Rad Laboratories, Inc.** · Class II · device recall initiated 2019-11-01.

## 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

## 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.

## 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.

## Key facts

- **Recall number:** Z-0082-2022
- **Recalling firm:** Bio-Rad Laboratories, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-01
- **Report date:** 2021-10-20
- **Termination date:** 2023-09-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Redmond, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0082-2022

## Citation

> AI Analytics. FDA recall Z-0082-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0082-2022. Source: US FDA. Licensed CC0.

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