# FDA recall Z-1796-2018

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2017-12-14.

## Product

Dimension Lipase Flex¿ Reagent Cartridge -  ( Lipase-esterase, enzymatic, photometric, lipase)

## Reason for recall

Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-to-lot limits.

## Distribution

Domestic and Foreign consignees

## Key facts

- **Recall number:** Z-1796-2018
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-14
- **Report date:** 2018-05-16
- **Termination date:** 2020-12-03

- **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-1796-2018

## Citation

> AI Analytics. FDA recall Z-1796-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1796-2018. Source: US FDA. Licensed CC0.

---

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