# FDA recall Z-1377-2023

> **Bio-Rad Laboratories, Inc.** · Class II · device recall initiated 2023-02-21.

## Product

BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD

## Reason for recall

Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8  96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1  98.8%). The reduction in specificity may lead to an increase in the number of false positives.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden.

## Key facts

- **Recall number:** Z-1377-2023
- **Recalling firm:** Bio-Rad Laboratories, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-21
- **Report date:** 2023-04-19

- **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-1377-2023

## Citation

> AI Analytics. FDA recall Z-1377-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1377-2023. Source: US FDA. Licensed CC0.

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