# FDA recall Z-1913-2019

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2019-05-03.

## Product

ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.

## Reason for recall

A steady upward trend in blank (u) absorbance was observed

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-1913-2019
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-03
- **Report date:** 2019-07-10
- **Termination date:** 2021-01-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1913-2019

## Citation

> AI Analytics. FDA recall Z-1913-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1913-2019. Source: US FDA. Licensed CC0.

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