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U.S. Department of Health and Human Services

Class 2 Device Recall Alinity c Cuvette Segments

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 Class 2 Device Recall Alinity c Cuvette Segmentssee related information
Date Initiated by FirmApril 15, 2019
Create DateJune 02, 2019
Recall Status1 Terminated 3 on October 13, 2020
Recall NumberZ-1709-2019
Recall Event ID 82644
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductAlinity 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.
Code Information All serial numbers
FEI Number 3002809144
Recalling Firm/
Manufacturer		 Abbott Gmbh & Co. KG
Max-Planck-Ring 2
65205
Wiesbaden Germany
For Additional Information ContactAlbert Chianello
224-668-1923
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionOn 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 Commerce19,184
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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