DonorScreen-HLA® Class I and Class II DSI+IIRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888234500193), received between May 24, 2018 and Jul 24, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2018False Positive Result; False Positive Result

  ON (B)(6) 2016 CUSTOMER CONTACTED TECHNICAL SUPPORT WITH A COMPLAINT (B)(4) FOR DONOR SCREEN (DSI+II) LOT 3003895AB. THEY STATED THAT THEY HAD CONDUCTED A SMALL STUDY CONSISTING OF 284 NEVER PREGNANT/TRANSFUSED FEMALE DONORS. THE RESULTS FROM THAT STUDY RESULTED IN 14% OF THOSE DONORS BEING POSITIVE FOR HLA CLASS I AND 74% BEING POSITIVE FOR HLA CLASS II. THE CUSTOMER ALSO STATED THAT THEY WERE EXPERIENCING A HIGHER THAN EXPECTED REACTIVITY RATE OF 24.7%. THE CUSTOMER ALSO STATED THAT THE RESULTS FOR 3462 SAMPLES HAD BEEN REPORTED FROM SEPTEMBER 28, 2016 THROUGH OCTOBER 13, 2016. THE CUSTOMER PERFORMED THE TESTING PER THE DONOR SCREEN IFU (303456.IFUEN, REV. F) AND THE RESULTS WERE VALID. THE ROOT CAUSE OF THE UNEXPECTED INCREASE IN REACTIVITY RATE IS UNKNOWN. IMMUCOR MAKES NO CLAIMS ON THE REACTIVITY RATES WITHIN THE DONOR SCREEN POPULATION OF DONORS. PER THE IFU, THE PRESENCE OF IMMUNE COMPLEXES OR OTHER IMMUNOGLOBULIN AGGREGATES IN THE SAMPLE MAY CAUSE AN INCREASED NON-SPECIFIC BINDING AND PRODUCE FALSE-POSITIVE RESULTS IN THE ASSAY. THE ISSUE IS SAMPLE DEPENDENT. THERE WAS NO REPORTED HARM TO THE PATIENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7714605 ↗
• MalfunctionJul 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2016, MSDTS CONTACTED TECHNICAL SUPPORT WITH A COMPLAINT ((B)(4)) FOR DONORSCREEN CLASS I/II ASSAY (DSI+II). THE BIO-RAD QUICKSTEP (9163600075) WAS PERFORMING A 90 SAMPLE RUN OF DONORSCREEN CLASS I/II AND THE SYSTEM REQUIRED ONLY 1 BOTTLE OF DILUTED CONJUGATE. PER THE DONORSCREEN INSTRUCTIONS FOR USE (IFU), WHEN RUNNING < 88 SAMPLES, ONLY ONE BOTTLE IS REQUIRED. THE CUSTOMER WAS CONCERNED WITH THE VALIDITY OF THE RUNS.

  Patient problems: Missing Value Reason; No Known Impact Or Consequence To Patient

  MAUDE report 7711693 ↗
• MalfunctionJul 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMMUCOR RECEIVED A CUSTOMER COMPLAINT 08 FEBRUARY 2018 ((B)(4)) BECAUSE THE CUSTOMER RECEIVED DISCREPANT RESULTS ON THE SAME SAMPLE. A NEGATIVE RESULT WAS OBTAINED FOR HLA CLASS I USING DONORSCREEN-HLA CLASS I AND CLASS II ASSAY ON 02 FEBRUARY 2018. THE SAME SAMPLE WAS TESTED AGAIN ON (B)(4) 2018 RESULTING IN A POSITIVE RESULT. BOTH ASSAYS MET VALIDITY CRITERIA.

  Patient problems: No Code Available

  MAUDE report 7708092 ↗
• MalfunctionJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016 COMPLAINT #: (B)(4) WAS RECEIVED FOR LIFECODES DONORSCREEN-HLA DS I AND DS II QUICKSTEP 90 SAMPLE RUN ONLY REQUIRED 1 CONJUGATE SHOULD REQUIRE 2 CONJUGATES. CUSTOMER IS CONCERNED ABOUT THE VALIDITY OF THE RUNS. ON (B)(6) 2016 THE R & D QUICKSTEP WAS SET UP TO RUN 90 SAMPLES AND ONE BOTLE OF CONJUGATE (2 SUBSTRATE) WERE REQUIRED BY THE SYSTEM. WHEN 91 SAMPLES WERE SET UP, THE SYSTEM REQUIRED 2 BOTTLES OF CONJUGATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7649946 ↗
• MalfunctionMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DONORSCREEN-HLA CLASS I AND CLASS II ASSAY IS USED BY A LABORATORY GROUP, (B)(4) WHICH HAS SEVERAL SITES IN THE UNITED STATES. CTS REPORTED AN HLA CLASS II RESULT DISCREPANCY BETWEEN TESTING PERFORMED AT 2 SITES, (B)(4). THE SAMPLE WAS A FRESH SAMPLE, NEVER FROZEN, DRAWN ON (B)(6) 2018 IN 2 SEPERATE TUBES WHICH WAS REFRIGERATED UNTIL (B)(6) 2018 FOR TESTING. TESTING WAS PERFORMED ON (B)(6) 2018. THE TESTING WAS PERFORMED AT BOTH SITES ABOUT AN HOUR APART. DISCREPANCY IN RESULTS FOR TWO SAMPLES BETWEEN THE SITES WAS REPORTED. THERE IS CONFLICT IN THE INFORMATION FROM THE CUSTOMER WHERE THE CUSTOMER STATED ONE SAMPLE WAS AFFECTED BUT DATA AND SOME DESCRIPTION PROVIDED BY CUSTOMER IS THAT TWO SAMPLES WERE AFFECTED. THE HLA CLASS I RESULTS WERE NEGATIVE FOR THE SAMPLES AT BOTH SITES. SITE: QUICKSTEP SERIAL #: SAMPLE ID: RESULT: RESULT REPORTED KIT LOT #: 1, (B)(4) , (B)(4) - ( NEG), NO, 3006245A/B. 2, (B)(4), (B)(4) + (POS), YES, SAME. 1, (B)(4), (B)(4) - ( NEG), NO, SAME. 2, (B)(4), (B)(4) + (POS), YES, SAME. THE CUSTOMER STATED THAT THEIR QA DEPARTMENT DETERMINED THE POS (POSITIVE) RESULT WOULD BE REPORTED FOR THIS SAMPLE. FOUR CONTACTS WITH THE CUSTOMER WHO PLACED THE COMPLAINT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7542214 ↗
• MalfunctionMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USER LABORATORY NOTIFIED IMMUCOR GTI DIAGNOSTICS THAT THEY USED COMPONENTS FROM 2 LOTS OF PRODUCT DURING 3 TESTING RUNS. THE MISTAKE WAS IDENTIFIED DURING THE THIRD RUN WHICH WAS ABORTED. THE SAMPLES FROM THIS THIRD RUN WERE REPEATED USING KIT COMPONENTS FROM ONE LOT OF PRODUCT. THE TWO PRIOR RUNS, SAMPLES WHICH RESULTED AS POSITIVE WERE REGARDED AS SUCH AND THE BLOOD PRODUCTS WHICH THE TESTING WAS PERFORMED ON WERE DISCARDED. SAMPLES WHICH ORIGINALLY RESULTED AS NEGATIVE WERE REPEATED USING COMPONENTS FROM ONE LOT OF PRODUCT. ONE SAMPLE WHICH ORIGINALLY RESULTED AS NEGATIVE IN TURN RESULTED AS POSITIVE. THE BLOOD PRODUCT WHICH THE SAMPLE WAS FROM WAS ABLE TO BE 'RECALLED' AND IT WAS DESTROYED. IMMUCOR COMPLAINT NUMBER FOR REPORT BY CUSTOMER WAS (B)(4) . NO PATIENT HARM OCCURRED. REGULATORY REPORTING WAS NOT PERFORMED AT THE TIME OF THE EVENT. THIS EVENT WAS CATEGORIZED AS NOT REQUIRING MDR REPORTING. A REVIEW OF POTENTIAL EVENTS DURING 2017 WAS PERFORMED IN JANUARY 2018. AT THAT TIME, IT WAS IDENTIFIED THAT DUE TO THIS BEING USER INCORRECT PERFORMANCE OF AN ASSAY LEADING TO A FALSE NEGATIVE RESULT, AN MDR WOULD BE SUBMITTED. THE PRODUCT LOTS USED WERE: 3004096A AND 3004609A. THE D

  Patient problems: No Patient Involvement

  MAUDE report 7542131 ↗