# FDA recall Z-1572-2023

> **Bio-Rad Laboratories, Inc.** · Class II · device recall initiated 2023-02-28.

## Product

BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

## Reason for recall

APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.

## Distribution

US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, HI, IL, IN, KS, KY, LA, MI, MO, NC, ND, NE, NJ, NM, NY, OH, OK, PR,SC, TN, TX, UT, VT.

## Key facts

- **Recall number:** Z-1572-2023
- **Recalling firm:** Bio-Rad Laboratories, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-28
- **Report date:** 2023-05-17

- **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-1572-2023

## Citation

> AI Analytics. FDA recall Z-1572-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1572-2023. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*