# FDA recall Z-2425-2021

> **Siemens Healthcare Diagnostics, Inc** · Class II · device recall initiated 2021-07-06.

## Product

Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.  SMN: 10995477

## Reason for recall

Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers

## Distribution

Worldwide distribution.  US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam

## Key facts

- **Recall number:** Z-2425-2021
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-06
- **Report date:** 2021-09-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Walpole, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2425-2021

## Citation

> AI Analytics. FDA recall Z-2425-2021. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2425-2021. Source: US FDA. Licensed CC0.

---

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