# FDA recall Z-0125-2022

> **Siemens Healthcare Diagnostics, Inc** · Class II · device recall initiated 2021-09-28.

## Product

Atellica IM 1600 Analyzer, SMN 11066000

## Reason for recall

Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.

## Distribution

Domestic distribution to AZ  CA  CO  GA  ID  KS  MO  MT  NC  NE  NM  NV  OH  OK  OR  PA  TN  TX  UT  VA  WA  WI  WY.    Foreign distribution worldwide.

## Key facts

- **Recall number:** Z-0125-2022
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-28
- **Report date:** 2021-10-27

- **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-0125-2022

## Citation

> AI Analytics. FDA recall Z-0125-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0125-2022. Source: US FDA. Licensed CC0.

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