# FDA recall Z-1252-2022

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2022-04-13.

## Product

Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens.  Siemens Material Number (SMN):	11066001

## Reason for recall

Lots incompatible with Test Definition (TDef) Version 1.4,  potentially lead to the generation of erroneous total T3 results

## Distribution

Worldwide distribution - US Nationwide and the countries of Albania, Argentina, Austria, Bahamas, Bangladesh, Belgium, Brazil, Chile, China, Columbia, Croatia, Czech¿Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Latvia, Malaysia, Mexico, Netherlands, Paraguay, Peru, Philippines, Portugal, Romania,  Russian¿Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United Kingdom, Vietnam.

## Key facts

- **Recall number:** Z-1252-2022
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-13
- **Report date:** 2022-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1252-2022

## Citation

> AI Analytics. FDA recall Z-1252-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1252-2022. Source: US FDA. Licensed CC0.

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