Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. CAPTURE-R READY-SCREEN (3); REAGENT RED BLOOD CELLS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

IMMUCOR, INC. CAPTURE-R READY-SCREEN (3); REAGENT RED BLOOD CELLS Back to Search Results
Catalog Number 0066815
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/01/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
On (b)(6) 2016, the (b)(4) laboratory received and tested a patient blood sample, and also three of the four crossmatched blood products from the (b)(6) customer site.The (b)(4)laboratory found the antibody screen to be (b)(6) and (b)(6) outcomes with two of the three crossmatched blood products.The (b)(4) laboratory reproduced the customer's issue.
 
Event or Problem Description
On (b)(6) 2016, a customer site in (b)(6) reported an unexpected negative antibody screen when using capture-r ready-screen (3) on a galileo echo instrument.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CAPTURE-R READY-SCREEN (3)
Common Device Name
REAGENT RED BLOOD CELLS
Manufacturer (Section D)
IMMUCOR, INC.
3130 gateway drive
norcross GA 30091 5625
MDR Report Key5980595
Report Number1034569-2016-00251
Device Sequence Number40244
Product Code KSZ
UDI-Device Identifier10888234001478
UDI-Public10888234001478
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
102707/5045
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Medical Technologist
Type of Report Initial
Report Date (Section B) 09/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Medical Technologist
Device Expiration Date09/20/2016
Device Catalogue Number0066815
Device Lot NumberJ076
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/01/2016
Initial Report FDA Received Date09/27/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-