# FDA recall Z-1197-2019

> **Abbott Gmbh & Co. KG** · Class II · device recall initiated 2019-02-26.

## Product

Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: 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. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c processing module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).

## Reason for recall

The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity s System.

## Distribution

Worldwide distribution - US Nationwide in the states of AR, CA, GA, ME, MN, MO, NY, OK, SC, TN, TX, UT, and VA, and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, LATVIA, LEBANON, MADAGASCAR, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, and VIETNAM.

## Key facts

- **Recall number:** Z-1197-2019
- **Recalling firm:** Abbott Gmbh & Co. KG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-26
- **Report date:** 2019-04-24
- **Termination date:** 2022-09-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1197-2019

## Citation

> AI Analytics. FDA recall Z-1197-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1197-2019. Source: US FDA. Licensed CC0.

---

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