Terminated

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.

FDA Recall Z-1709-2019 · Posted None

Recalling FirmAbbott Gmbh & Co. KG

Recall StatusTerminated

Product CodeJJE

Date Initiated2019-04-15

Date Terminated2020-10-13

Product Quantity19,184

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.