# FDA recall Z-1709-2019

> **Abbott Gmbh & Co. KG** · Class II · device recall initiated 2019-04-15.

## Product

Alinity c Cuvette Segments, List Number 04S47-01  Product Usage:  The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology.

## Reason for recall

Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designed height. This may result in inadequate dispense into specific cuvettes due to the sample probe being unable to make efficient contact with the cuvette bottom.

## Distribution

US Nationwide Distribution- AL, AR,CA, FL, GA, IL, LA, MA, ME, MN, MO, NJ, NY, OK, SC, TN, TX, UT, & VA    WORLDWIDE - Albania, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Norway, Pakistan, Philippines, Poland, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Thailand, Trinidad & Tobago, Turkey, United Kingdom, and Vietnam.

## Key facts

- **Recall number:** Z-1709-2019
- **Recalling firm:** Abbott Gmbh & Co. KG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-15
- **Report date:** 2019-06-12
- **Termination date:** 2020-10-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wiesbaden, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1709-2019

## Citation

> AI Analytics. FDA recall Z-1709-2019. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-1709-2019. Source: US FDA. Licensed CC0.

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