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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. TPHA SCREEN TEST CELLS FOR THE DETECTION OF ANTIBODIES TO TREPONEMA PALLIDUM

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IMMUCOR, INC. TPHA SCREEN TEST CELLS FOR THE DETECTION OF ANTIBODIES TO TREPONEMA PALLIDUM Back to Search Results
Catalog Number 0066826
Device Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/10/2017
Event Type  malfunction  
Manufacturer Narrative
The immucor review concluded that the probability of occurrence of harm (poh) is improbable (b)(6). The severity of a transfusion transmitted (b)(6) is considered serious because the resulting injury (infection) would require medical attention. This mdr is linked to (b)(6).
 
Event Description
On (b)(6) 2017, immucor deemed an mdr reportable to fda, due thirty (30) days from the date of (b)(6) 2017 for tpha screen test cells (lot number 280006).
 
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Brand NameTPHA SCREEN TEST CELLS
Type of DeviceFOR THE DETECTION OF ANTIBODIES TO TREPONEMA PALLIDUM
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 Key6592307
MDR Text Key76134028
Report Number1034569-2017-00094
Device Sequence Number1
Product Code MYR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK120021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/30/2017
Device Catalogue Number0066826
Device Lot Number280006
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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