# FDA recall Z-1196-2019

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

## Product

Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

## 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-1196-2019
- **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-1196-2019

## Citation

> AI Analytics. FDA recall Z-1196-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1196-2019. Source: US FDA. Licensed CC0.

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