# FDA recall Z-3118-2017

> **Beckman Coulter Inc.** · Class II · device recall initiated 2017-07-20.

## Product

Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30.  The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada.  Used in laboratory testing.

## Reason for recall

Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.

## Distribution

Distribution US nationwide.

## Key facts

- **Recall number:** Z-3118-2017
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-20
- **Report date:** 2017-09-20
- **Termination date:** 2018-01-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3118-2017

## Citation

> AI Analytics. FDA recall Z-3118-2017. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-3118-2017. Source: US FDA. Licensed CC0.

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