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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE R SELECT; AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM
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IMMUCOR, INC. CAPTURE R SELECT; AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM Back to Search Results
Catalog Number 6446
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
This report summarizes 1 malfunction events.A review of the event indicated that one (1) patient sample test using the capture-r select reagent on an automated blood bank system produced a positive crossmatch result.The result was a false positive given customer testing using liss/tube and peg/tube methods showed incompatibility.Through post event tests and investigations, no specific causes were determined for the malfunction.
 
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Brand Name
CAPTURE R SELECT
Type of Device
AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM
Manufacturer (Section D)
IMMUCOR, INC.
3130 gateway drive
norcross GA 30091 5625
Manufacturer (Section G)
IMMUCOR, INC.
3130 gateway drive
norcross GA 30091 5625
Manufacturer Contact
howard yorek
3130 gateway drive
norcross, GA 30091-5625
7704412051
MDR Report Key9252169
MDR Text Key209442521
Report Number1034569-2019-00146
Device Sequence Number1
Product Code KSZ
UDI-Device Identifier10888234000655
UDI-Public10888234000655
Combination Product (y/n)N
PMA/PMN Number
BK040024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial
Report Date 10/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number6446
Device Lot NumberSC612
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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