# FDA recall Z-2068-2018

> **Tosoh Bioscience Inc** · Class II · device recall initiated 2018-03-05.

## Product

ST-AIA PACK PAP; Part Number: 025262     Assay, Prostate

## Reason for recall

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

## Distribution

Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.

## Key facts

- **Recall number:** Z-2068-2018
- **Recalling firm:** Tosoh Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-05
- **Report date:** 2018-06-13
- **Termination date:** 2020-08-31

- **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-2068-2018

## Citation

> AI Analytics. FDA recall Z-2068-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2068-2018. Source: US FDA. Licensed CC0.

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