Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Slides 800-20202-08Recalls & reported problems
Bioarray Solutions Ltd · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Immucor PreciseType HEA BeadChip test slide kit, a molecular test for blood group antigens, has 116 adverse event reports on file. Many describe results that disagreed with standard serology tests, including false positive and false negative calls. Most reports describe no known impact on patients, and the reports include no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 116
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 10888234100065), received between Dec 29, 2015 and May 1, 2025 — classified as 116 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (67 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, 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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings67
- Incorrect Or Inadequate Test Results27
- False Positive Result12
- False Negative Result7
- Device Operates Differently Than Expected3
- Appropriate Device Problem Term/Code Not Available2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Known Impact Or Consequence To Patient80
- No Information12
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information6
- No Code Available3
- No Consequences Or Impact To Patient3
- Test Result2
Recent adverse event reports
The 25 most recent of 116 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
CUSTOMER REPORTED DISCREPANCY BETWEEN SEROLOGY AND PRECISETYPE HEA BEADCHIP SLIDE KIT. ON THE SAME KIT, THE CUSTOMER REPORTED TWO DISCREPANCY SAMPLES. THE FIRST SAMPLE TYPED C+ WITH SEROLOGY BUT TYPED C- WITH PRECISETYPE HEA BEADCHIP KIT. THE SECOND SAMPLE TYPED C- WITH SEROLOGY BUT TYPED C+ WITH PRECISETYPE HEA BEADCHIP KIT.
Patient problems: Insufficient Information
MAUDE report 21945777 ↗MalfunctionAug 7, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
INITITAL INVESTIGATION: LAB REPORTED A TYPING DISCREPANCY BETWEEN HEA BEADCHIP AND SEROLOGY. THE DONOR SAMPLE RESULTED IN C POSITIVE ON HEA BEADCHIP KIT BUT DONOR TYPED C NEGATIVE WITH ALBACLONE AND IMMUCOR ANTISERA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19929438 ↗MalfunctionJan 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
CUSTOMER REPORTED ABOUT JKB DISCREPANCY. CUSTOMER STATED PATIENT RESULT IS JK(B-) ON PRECISETYPE HEA BEADCHIP KIT AND A DIFFERENT MOLECULAR PLATFORM. SAME SAMPLE TESTS JK(B+) WITH TWO SEROLOGIC TESTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18503916 ↗MalfunctionMay 18, 2023False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings
CUSTOMER INQUIRED ABOUT AN INDETERMINED CALL ( IC) ON A RUN. UPON REVIEW, IC IS ON V ANTIGEN. CUSTOMER REPEATED THE SAMPLE AND GOT A NEGATIVE RESULT FOR V ANTIGEN. THEY DID FURTHER INVESTIGATION AND DETERMINED THE SAMPLE HAD BEEN PREVIOUSLY TESTED IN (B)(6) 2021, WHICH HAD A POSITIVE RESULT FOR V ANTIGEN. ONLY KNOWN PATIENT HISTORY IS SICKLE CELL (SCD), NO HISTORY OF TRANSPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16956398 ↗MalfunctionSep 24, 2022False Positive Result; False Positive Result
DONOR WHO HAS TYPED AS C NEGATIVE MULTIPLE TIMES BY SEROLOGY (MANUAL AND AUTOMATED) THAT IS TESTING POSITIVE WITH HEA. MOLECULAR RESULTS TESTED MULTIPLE TIMES WITH 2 DIFFERENT EXTRACTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15480722 ↗MalfunctionSep 24, 2022False Positive Result; False Positive Result
DONOR WHO HAS TYPED AS C NEGATIVE MULTIPLE TIMES BY SEROLOGY (MANUAL AND AUTOMATED) THAT IS TESTING POSITIVE WITH HEA. MOLECULAR RESULTS TESTED MULTIPLE TIMES WITH 2 DIFFERENT EXTRACTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15476904 ↗MalfunctionAug 15, 2022Incorrect, Inadequate or Imprecise Result or Readings
CUSTOMER REPORTED A POTENTIAL DISCREPANCY AS A SAMPLE TYPED E+ ONCE BY HEA AND E- TWICE BY HEA UPON RETEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15229190 ↗MalfunctionDec 23, 2021False Positive Result; False Positive Result
ON (B)(6) 2021 A CUSTOMER IN (B)(6) REPORTED A POTENTIAL DISCREPANCY WITH HEA BEADCHIP RESULTS VERSUS SEROLOGY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13081704 ↗MalfunctionDec 9, 2021False Positive Result; False Positive Result
ON (B)(6) 2021 A CUSTOMER REPORTED DISCREPANCY IN DETECTING JKB ANTIGEN USING BEADCHIP((B)(4)) AND REQUESTED ASSISTANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12972702 ↗MalfunctionDec 9, 2021False Positive Result; False Positive Result
ON (B)(6) 2021, A CUSTOMER REPORTED A DISCREPANCY ON A DONOR SAMPLE AND REQUESTED ASSISTANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12965920 ↗MalfunctionSep 10, 2021Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS S+ USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE S-.
Patient problems: Insufficient Information
MAUDE report 12456639 ↗MalfunctionAug 25, 2021Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS JKA+ USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE JKA-.
Patient problems: Insufficient Information
MAUDE report 12367317 ↗MalfunctionAug 16, 2021Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS K+ USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE K-.
Patient problems: Insufficient Information
MAUDE report 12324478 ↗MalfunctionMar 15, 2021Incorrect, Inadequate or Imprecise Result or Readings
CUSTOMER REPORTED A POSSIBLE DISCREPANCY BETWEEN SEROLOGICAL BIG C TYPING AND BIOARRAY HEA MOLECULAR BEADCHIP KIT BIG C TYPING.
Patient problems: Insufficient Information
MAUDE report 11489909 ↗MalfunctionDec 5, 2020Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS JKB+ USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE JKB-.
Patient problems: Insufficient Information
MAUDE report 10950689 ↗MalfunctionOct 15, 2020Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS JKB+ USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE JKB-.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10683760 ↗MalfunctionAug 5, 2020Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS JKA+ USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE JKA-.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10368052 ↗MalfunctionMay 29, 2020Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS N- USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE N+.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10101123 ↗MalfunctionMar 5, 2020Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS C+ USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE C-.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9792572 ↗MalfunctionDec 20, 2019Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS C+ USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE C-.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9503506 ↗MalfunctionSep 16, 2019Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS K+ USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE K-.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9071196 ↗MalfunctionSep 16, 2019Appropriate Device Problem Term/Code Not Available
THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS K+ USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE K-.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9070997 ↗MalfunctionAug 16, 2019Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS S+ USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE S-.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8903450 ↗MalfunctionAug 9, 2019Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS M- USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE M+.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8880392 ↗MalfunctionJun 12, 2019Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS S+S- USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE S+S+.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8691623 ↗
Other Molecular Erythrocyte Typing Test devices
- ID CORE XT v3Progenika Biopharma, SA · Molecular Erythrocyte Typing Test42 reports
- Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Plate 800-20202-96Bioarray Solutions Ltd · Molecular Erythrocyte Typing Test9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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