Recall Z-1709-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Gmbh & Co. KG
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.
| Date | Apr 15, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by 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. |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.