# FDA recall Z-2967-2020

> **Tosoh Bioscience Inc** · Class II · device recall initiated 2020-08-07.

## Product

Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG  Part number 020361    The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay

## Reason for recall

Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.

## Distribution

Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador.

## Key facts

- **Recall number:** Z-2967-2020
- **Recalling firm:** Tosoh Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-07
- **Report date:** 2020-09-23
- **Termination date:** 2021-06-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grove City, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2967-2020

## Citation

> AI Analytics. FDA recall Z-2967-2020. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-2967-2020. Source: US FDA. Licensed CC0.

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