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. REMOVALS AND CORRECTIONS REPORT NUMBER: 3005094123-11/21/18-002-R.

Description of Event or Problem

THE CUSTOMER WAS UNABLE TO TURN THE MICROPARTICLE PORTION OF THE ALINITY I FERRITIN REAGENT CARTRIDGE LOT 93238UI00 ON THE ALINITY I PROCESSING MODULE. THERE WAS NO REPORT OF ANY PATIENT IMPACT DUE TO THE POTENTIAL DELAY IN GENERATING FERRITIN RESULTS.