MalfunctionPSZ
BINAXNOW INFLUENZA A B CARD 2
Received May 12, 2020 · Event occurred Mar 1, 2020
Report 10046508 · MDR key 10046508
Device
Generic name
Rapid Flu Test
Manufacturer
Alere Scarborough, Inc.Model number
575-000Catalog number
575-000
Lot number
113348
Product problems
- Device Damaged Prior to Receipt by User
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
NO SOLUTION IN ELUTION VIAL TO RUN INFLUENZA TEST. ELUTION VIAL WAS EMPTY AND CAP WAS INTACT PRIOR TO OPENING. MANUFACTURER RESPONSE FOR RAPID FLU TEST, BINAX NOW INFLUENZA A&B CARD 2 (PER SITE REPORTER). EVENT REPORTED TO USPRODUCTSUPPORT@ABBOTT.COM. ALERE CASE #(B)(4). RESPONSE RECEIVED FROM ALERE TECHNICAL SERVICES. NO FURTHER FEEDBACK OR INSTRUCTIONS RECEIVED.