ALINITY I FERRITIN
Received Dec 20, 2018 · Event occurred Nov 22, 2018
Report 3005094123-2018-00263 · MDR key 8186942
Device
Product problems
- Unable to Obtain Readings
- Device Damaged Prior to Use
- Unable to Obtain Readings
- Device Damaged Prior to Use
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
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 ERROR CODE 5817 (UNABLE TO INITIALIZE MODULE DUE TO PREVIOUS LOAD OR UNLOAD ERROR. REMOVE REAGENT CARTRIDGE OR RACK WITH LOAD OR UNLOAD ERROR FROM REAGENT CAROUSEL) WHILE LOADING ALINITY I FERRITIN REAGENT 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.
Remedial action
- Recall