ALINITY I FERRITIN

Additional Manufacturer Narrative

A PRODUCT RECALL LETTER WAS ISSUED TO CUSTOMERS WHO RECEIVED SHIPMENTS OF THE AFFECTED ALINITY REAGENTS TO INFORM THEM OF THE MANUFACTURING ISSUE IDENTIFIED WITH THE REAGENT CARTRIDGE BOTTLE NECKS. THE LETTER INSTRUCTS THE CUSTOMER TO MANUALLY INSPECT EACH REAGENT CARTRIDGE IN INVENTORY BEFORE USE. STAT ASSAYS, ALINITY I STAT HIGH SENSITIVE TROPONIN- I AND ALINITY I TOTAL B-HCG, SHOULD BE INSPECTED FIRST AS A PRIORITY TO ENSURE NO DELAY IN TESTING FOR THOSE ASSAYS. THE FOLLOWING ALINITY I FERRITIN LOTS ARE INCLUDED IN THIS CORRECTION: 91532UI00, 93238UI00. THE FDA DIVISION HAS BEEN NOTIFIED OF THIS PRODUCT RECALL. REMOVALS AND CORRECTIONS REPORT NUMBER: 3005094123-11/21/18-002-R. NOTE: ADDITIONAL PRODUCTS WITHIN THE SCOPE OF THIS PRODUCT RECALL THAT WERE DISTRIBUTED IN THE U.S. HAVE BEEN FILED UNDER MDRS 3005094123-2018-00127, 3005094123-2018-00128, 3005094123-2018-00129, 3005094123-2018-00130, 3005094123-2018-00131 AND 3005094123-2018-00133. IMPACTED PRODUCTS THAT WERE NOT DISTRIBUTED IN THE U.S. HAVE ALSO BEEN INCLUDED IN THE SCOPE OF THIS FIELD ACTION DOCUMENTATION. ADDITIONAL LOT INFORMATION: LOT 93238UI00: MANUFACTURE DATE: 11/02/2018, EXPIRATION DATE: 09/05/2019.

Description of Event or Problem

ABBOTT LABORATORIES HAS BECOME AWARE OF A MANUFACTURING ISSUE THAT CAN RESULT IN DAMAGE TO A BOTTLE NECK IN SOME REAGENT CARTRIDGES. IF A BOTTLE NECK IS DAMAGED, IT MAY CAUSE A FAILURE DURING THE REAGENT LOADING PROCESS ON THE ALINITY I INSTRUMENT. WHEN THE FAILURE OCCURS, ERROR CODES WILL BE GENERATED WHICH MAY LEAD TO THE POTENTIAL OF DELAYED PATIENT RESULTS. NO PATIENT INJURY HAS BEEN REPORTED DUE TO THIS ISSUE.