# FDA recall Z-1316-2019

> **Abbott Gmbh & Co. KG** · Class II · device recall initiated 2019-03-07.

## Product

Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02.        Product  Usage:  The Alinity i (LN 03R65 01) 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. The Alinity c (LN 03R67 01) 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 concentr

## Reason for recall

Potential performance issues in the Alinity-ci software version 2.5.1

## Distribution

AR, AZ, CA, FL, GA, IL, MA, ME, MN, MO, NY, OK, SC, TN, TX, UT, VA, WI, and Puerto Rico  ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA,   CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA,  KUWAIT, LATVIA, LEBANON, MADAGASCAR, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SERBIA, SINGAPORE,  SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE,   UK, and VIETNAM.

## Key facts

- **Recall number:** Z-1316-2019
- **Recalling firm:** Abbott Gmbh & Co. KG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-07
- **Report date:** 2019-05-22
- **Termination date:** 2025-02-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1316-2019

## Citation

> AI Analytics. FDA recall Z-1316-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1316-2019. Source: US FDA. Licensed CC0.

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