FDA recall Z-1709-2019

Abbott Gmbh & Co. KG · Class II · device

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.

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.

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.

Key facts

Status
Terminated
Initiation date
2019-04-15
Report date
2019-06-12
Termination date
2020-10-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wiesbaden, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1709-2019