Z-1709-2019Class II

Alinity c Cuvette Segments, List Number 04S47-01

Name: Z-1709-2019 Alinity c Cuvette Segments, List Number 04S47-01
Creator: Abbott Gmbh & Co. KG
Published: 2019-04-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-04-15 / Terminated

FDA source

Abbott Gmbh & Co. KG began a recall of 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... on 2019-04-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1709-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-15
Posted: 2019-06-02
Terminated: 2020-10-13
Recalling firm: Abbott Medical
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
FDA root cause: Under Investigation by firm
Action: On April 15, 2019, Abbott sent Product Correction Urgent - Immediate Action Required letters to all impacted Customers. US customers were sent these letters via FedEx priority overnight express while customers outside the US were notified via mailings or visits. The letters sent to US consignees were accompanied by Customer Reply form which were to be completed and sent back to Abbott.
Quantity in commerce: 19,184
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.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1709-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1709-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-02

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)