FDAClass IIJune 12, 2019

Alinity c Cuvette Segments recall

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…

Why was Alinity c Cuvette Segments recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All serial numbers

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…
Recalling firm
Abbott Gmbh & Co. KG
Quantity
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.
Recall date
June 12, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls