MalfunctionMLH
HIV ANTIGEN ELISA TEST
Received May 14, 1996 · Event occurred Apr 15, 1996
Report MW1009097 · MDR key 32999
Device
Generic name
In Vitro Assay For Blood Donor Screening
Manufacturer
Ortho Diagnostic SystemsModel number
P24Catalog number
933180
Lot number
2065K536
Product problems
- Performance
- Product Quality Problem
Patient
NO INFO
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
RECURRENT LACK OF PERFORMANCE OF CONTROLS IN KIT FOR BLOOD DONOR SCREENING. NO RESPONSE FROM VENDOR TO TRY TO CORRECT THE PROBLEM. BLOOD DONOR TESTING DONE DAILY WITH REPEATED ASSAY FAILURES. VENDOR ASSUMES NO RESPONSIBILITY FOR LACK OF KIT PERFORMANCE.