Capture-R Ready-Screen (3)Recalls & reported problems across all models
Immucor, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 313
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 5 models of Capture-R Ready-Screen (3) by Immucor, Inc. in the FDA's device registry (GUDID). Together they are named in 313 adverse event reports in the FDA's MAUDE database, received between Apr 20, 2016 and Aug 5, 2025 — classified as 313 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (297 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Capture-R Ready-Screen (3) problems
Device problems
- False Negative Result297
- Device Operates Differently Than Expected5
- Incorrect, Inadequate or Imprecise Result or Readings5
- Unexpected Therapeutic Results2
- Adverse Event Without Identified Device or Use Problem1
- False Reading From Device Non-Compliance1
- Improper Device Output1
- Incorrect Or Inadequate Test Results1
Patient problems
- No Consequences Or Impact To Patient155
- No Known Impact Or Consequence To Patient134
- Patient Problem/Medical Problem6
- No Clinical Signs, Symptoms or Conditions5
- No Information4
- Chills3
- Transfusion Reaction3
- Fever2
Capture-R Ready-Screen (3) models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 200 reports
- 86 reports
- 16 reports
- 9 reports
- 2 reports
Recent Capture-R Ready-Screen (3) adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2025False Negative Result; False Negative Result
ON (B)(6) 2025 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULT WITH CAPTURE-R READY-SCREEN 3 ON AN ECHO LUMENA INSTRUMENT. CUSTOMER REPORTED A HEMOLYTIC TRANSFUSION REACTION WAS OBSERVED.
Patient problems: Transfusion Reaction
MAUDE report 22719142 ↗MalfunctionJun 9, 2025False Negative Result; False Negative Result
ON (B)(6) 2025 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULT WITH CAPTURE-R READY-SCREEN 3 ON AN ECHO LUMENA INSTRUMENT. CUSTOMER REPORTED A DELAYED TRANSFUSION REACTION.
Patient problems: Transfusion Reaction
MAUDE report 22171789 ↗MalfunctionApr 4, 2023False Negative Result; False Negative Result
ON (B)(6) 2023, A CUSTOMER STATED THAT A PATIENT HAD A TRANSFUSION REACTION FOLLOWING RECEIPT OF ONE UNIT OF K+ BLOOD.
Patient problems: Transfusion Reaction
MAUDE report 16679202 ↗MalfunctionDec 23, 2022False Negative Result; False Negative Result
ON (B)(6) 2022 A CUSTOMER SITE IN THE UK REPORTED THAT THEY HAD RECEIVED UNEXPECTED NEGATIVE RESULTS FOR AN ANTIBODY SCREEN USING CAPTURE-R READY-SCREEN 3 ON THE EUROPEAN VERSION OF THE NEO IRIS INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16041119 ↗MalfunctionDec 30, 2021False Negative Result; False Negative Result
ON (B)(6) 2021 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE SCREEN WITH CAPTURE-R READY-SCREEN 3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13122321 ↗MalfunctionNov 27, 2021False Negative Result; False Negative Result
ON (B)(6) 2021 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULT FOR PRE-TRANSFUSION SAMPLE WITH USING CAPTURE-R READY-SCREEN 3 ON AN ECHO V2.0 INSTRUMENT AND A DELAYED TRANSFUSION REACTION WITH ONE PATIENT.
Patient problems: Jaundice
MAUDE report 12879735 ↗MalfunctionOct 2, 2021False Negative Result; False Negative Result
ON (B)(6) 2021 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULT FOR PRE-TRANSFUSION SAMPLE WITH USING CAPTURE-R READY-SCREEN 3 ON AN ECHO LUMENA INSTRUMENT AND A HEMOLYTIC TRANSFUSION REACTION WITH ONE PATIENT. CUSTOMER STATED THAT THIS IS A SAMPLE RELATED ISSUE.
Patient problems: Chest Pain; Chills
MAUDE report 12566238 ↗MalfunctionJun 8, 2021False Negative Result; False Negative Result
ON (B)(6) 2021 A CUSTOMER REPORTED THAT A PATIENT HAD A SUSPECTED FEBRILE HEMOLYTIC REACTION WHEN RECEIVING PART OF ONE BLOOD UNIT THAT WAS ELECTRONICALLY CROSS MATCHED BASED ON NEGATIVE ECHO LUMENA SCREEN RESULT.
Patient problems: Chills
MAUDE report 11953906 ↗MalfunctionApr 13, 2021False Negative Result; False Negative Result
ON MARCH 15, 2021 A CUSTOMER REPORTED THAT A PATIENT HAD A TRANSFUSION REACTION CONSISTING OF CHILLS, RIGORS, AND ELEVATED BLOOD PRESSURE FOLLOWING TRANSFUSION OF A HALF UNIT OF K+ PRBC. PATIENT PRESENTED (B)(6) 2021 AS ANTIBODY SCREEN NEGATIVE. PATIENT RECEIVED MULTIPLE TRANSFUSIONS; ON FINAL UNIT (WHICH WAS (B)(6) 2021) A TRANSFUSION REACTION OCCURRED.
Patient problems: Chills
MAUDE report 11657055 ↗MalfunctionApr 7, 2021False Negative Result; False Negative Result
ON MARCH 12, 2021 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN RESULT WITH CAPTURE-R READY-SCREEN 3 LOT NUMBER R205 ON ECHO LUMENA INSTRUMENT SERIAL NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11632189 ↗MalfunctionFeb 5, 2021False Negative Result; False Negative Result
ON JANUARY 8, 2021 A CUSTOMER IN (B)(6) REPORTED AN UNEXPECTED NEGATIVE SCREEN RESULT WITH CAPTURE-R READY-SCREEN 3 ON THE NEO IRIS INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11290041 ↗MalfunctionDec 18, 2020False Negative Result; False Negative Result
ON (B)(6) 2020 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE SCREEN RESULT WITH CAPTURE-R READY-SCREEN 3 ON THE GALILEO NEO INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11039727 ↗MalfunctionJul 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES <NOE> 14 </NOE> MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT FOURTEEN (14) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY SCREEN 3 REAGENT ON AUTOMATED BLOOD BANK SYSTEMS PRODUCED UNEXPECTED NEGATIVE RESULTS FOR SPECIFIC ANTIBODIES. THE RESULTS REPRESENT FALSE NEGATIVES DUE TO PRIOR PATIENT HISTORIES OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODIES. THE MALFUNCTIONS DID NOT SHOW POSITIVE RESULTS AS EXPECTED FOR THE ANTI-JKA ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-FYA ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-C ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-E ANTIBODY ON ONE (1) OCCASION; THE ANTI-E ANTIBODY ON TWO (2) OCCASIONS; THE ANTI-K ANTIBODY ON FOUR (4) OCCASIONS; THE ANTI-JKB ANTIBODY ON ONE (1) OCCASION; THE ANTI-S ANTIBODY ON ONE (1) OCCASION AND THE ANTI-CW ANTIBODY ON ONE (1) OCCASION. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10345919 ↗MalfunctionApr 30, 2020False Negative Result; False Negative Result
THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT TEN (10) PATIENT SAMPLE TESTS USING THE CAPTURE-R READY SCREEN 3 REAGENT ON AUTOMATED BLOOD BANK SYSTEMS PRODUCED UNEXPECTED NEGATIVE RESULTS FOR SPECIFIC ANTIBODIES. THE RESULTS REPRESENT FALSE NEGATIVES DUE TO PRIOR PATIENT HISTORIES OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODIES. THE MALFUNCTIONS DID NOT SHOW POSITIVE RESULTS AS EXPECTED FOR THE ANTI-E ANTIBODY ON SIX (6) OCCASIONS; THE ANTI-E ANTIBODY ON ONE (1) OCCASION; THE ANTI-K ANTIBODY ON ONE (1) OCCASION AND THE ANTI-JKA ANTIBODY ON TWO (2) OCCASIONS. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10016302 ↗MalfunctionApr 13, 2020False Negative Result; False Negative Result
ON (B)(6) 2020 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WITH CAPTURE-R READY-SCREEN 3 ON THE GALILEO NEO INSTRUMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9955535 ↗
Other Immucor, Inc. products
All Immucor, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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