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 OBSERVED LOAD FAILURE ERROR CODES 5819, 5818, 5672 AND 5794 WHEN ATTEMPTING TO LOAD ALINITY I FERRITIN REAGENT CARTRIDGE LOT 91532UI00 ON THE ALINITY I PROCESSING MODULE. THERE WAS NO REPORT OF ANY PATIENT IMPACT DUE TO THE POTENTIAL DELAY IN GENERATING FERRITIN RESULTS.