Z-1709-2019 Class II Terminated
FDA device recall Z-1709-2019 was initiated by Abbott Gmbh & Co. KG on April 15, 2019 and is designated Class II. 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 u… The recall status is terminated (terminated October 13, 2020). Affected quantity: 19,184.
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2019
- Initiation Date
- April 15, 2019
- Termination Date
- October 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,184
Product Description
Reason for Recall
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.