ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A Adverse Event — Malfunction (MDR 2250051-2020-00016)

Name: ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A Adverse Event — Malfunction (MDR 2250051-2020-00016)
Creator: DeviceEvents

ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A Adverse Event — Malfunction (MDR 2250051-2020-00016) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A; Generic name: REAGENT RED BLOOD CELLS; Manufacturer: ORTHO CLINICAL DIAGNOS

Device	ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A
Generic name	REAGENT RED BLOOD CELLS
Manufacturer	ORTHO CLINICAL DIAGNOSTICS
Report number	2250051-2020-00016
Event type	Malfunction
Product problem	Y
Date received	2020-04-28
Report source	HEALTH PROFESSIONAL
Narrative	ORTHO PERFORMED RETAIN TESTING, BATCH REVIEW, COMPLAINT REVIEW BY LOT, DONOR HISTORY, AND DONOR COMPLAINT REVIEW. BASED UPON THE RESULTS OF THIS INVESTIGATION, THE REPORTED CUSTOMER ISSUE WAS UNABLE TO BE CONFIRMED. ALL RESULTS WERE SATISFACTORY. SAMPLE WAS NOT RETURNED TO ORTHO FOR FURTHER INVESTIGATION. (B)(4).
Source	openFDA MAUDE (device adverse events)

🔍 Search all device adverse events →

$1999/mo

Try DeviceEvents →