Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Plate 800-20202-96Recalls & reported problems
Bioarray Solutions Ltd · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888234102618), received between Dec 8, 2021 and Apr 24, 2025 — classified as 9 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (5 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
- False Negative Result5
- Incorrect, Inadequate or Imprecise Result or Readings4
- Unable to Obtain Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2025False Negative Result; False Negative Result
CUSTOMER REPORTED TYPING DISCREPANCY ON A SAMPLE FOR FYA WITH PRECISETYPE HEA PLATE USING LOT#: 22-157-V TYPED FY(A-) BUT SEROLOGY ON A SUBSEQUENT DONATION WAS FY(A+). CUSTOMER RE-RAN THE ORIGINAL DNA DONOR SAMPLE ON A SLIDE (HEAQ6165_8) WITH PRECISETYPE HEA SLIDE USING LOT#: 24-186-V AND OBTAINED FY(A+), MATCHING SEROLOGY. ALL OTHER ANTIGENS MATCHED THE ORIGINAL RUN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21905301 ↗MalfunctionMar 27, 2025False Negative Result; False Negative Result
INITIAL DESCRIPTION ON 27MAR2025: CUSTOMER REPORTED FY(A-) TYPING DISCREPANCY FOR TWO DIFFERENT SAMPLES ON POSITION G8 AND POSITION F9 USING PRECISETYPE HEA BEADCHIP PLATE (P/N 800-20202-96). THE CUSTOMER TESTED BOTH SAMPLES WITH SEROLOGY AND THE RESULTS TYPED FY(A+). THE CUSTOMER RERAN THE SAMPLES USING PRECISETYPE HEA BEADCHIP SLIDE (P/N 800-20202-08) USING LOT# 24-075 FOR PLATE POSITION G8 AND LOT#24-186 FOR PLATE POSITION F9. BOTH RE-RUN RESULTS TYPED FY(A+), MATCHING SEROLOGY.
Patient problems: Insufficient Information
MAUDE report 21713784 ↗MalfunctionApr 18, 2024Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings
CUSTOMER REPORTED PERFORMANCE ISSUES WITH THE SEVERAL PRECISETYPE HEA BEADCHIP PLATES ON LOT 22-202-V. POTENTIAL LOWER INTENSITY ACROSS PROBES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19137887 ↗MalfunctionAug 1, 2023False Negative Result; False Negative Result
MULTIPLE FALSE NEGATIVE CALLS ON FYA. POSSIBLE DISCREPANCY AS A SAMPLE TYPED FYA- AND UPON RETEST, THE SAME SAMPLE RESULTED IN FYA+. UPDATE AS OF 01AUG2023: TRENDING ANALYSIS DETERMINED THIS IS THE ONLY COMPLAINT FOR THIS LOT 22-117-V OF THIS COMPLAINT NATURE, HOWEVER THE SECOND INSTANCE OF THE CUSTOMER REPORTING FALSE FYA(0) RESULTS WITHIN THE PAST YEAR. THE FALSE FYA(0) RESULTS ARE CAUSED BY THE SIGNIFICANT CHANGE IN THE FYA/FYB DELTA VALUES FOR SAMPLES THAT SHOULD RESULT AS FYA(+) AND IS DUE TO THE REDUCED REACTIVITY OF THE FYA BEADS RELATIVE TO THE FYB BEADS OF THE BEADCHIPS. THE UNDERLYING ROOT CAUSE OF THE REDUCED REACTIVITY IS UNKNOWN AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17435683 ↗MalfunctionJan 4, 2023False Negative Result; False Negative Result
ON (B)(6) 2022, THE CUSTOMER REPORTED THAT TWO (2) FYA- DISCREPANCIES OCCURED WHILE TESTING WITH HEA LOT#22-141-V. THE CUSTOMER INFORMED BIOARRAY'S TECHNICAL SUPPORT SPECIALIST THAT SAMPLE (B)(4) TYPED FYA- ON PLATE HEAM5976_G3 AND TYPED FYA+ ON SLIDE HEAM0135_8. THIS WAS NOTICED AND RESULTS WERE NOT RELEASED HOWEVER SAMPLE (B)(4) ON PLATE HEAM5986_F8 RESULTED IN FYA-, BUT WAS ONLY DISCOVERED TO BE DISCORDANT WITH PREVIOUS TYPING PERFORMED AT NYBC ON PLATE HEAL4061_E11.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16099354 ↗MalfunctionDec 30, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
CUSTOMER REPORTED TWO RUN FAILURES. LOW SIGNAL (LS) AND INDETERMINED CALL (IC) WARNINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16080734 ↗MalfunctionJan 5, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2021 A CUSTOMER REPORTED POTENTIAL DISCREPANCIES WITH HEA BEADCHIP RESULTS AS THE SAMPLE TYPED E- TWICE AND E+ ONCE UPON THIRD REPEAT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13173068 ↗MalfunctionDec 29, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2021 A CUSTOMER REPORTED POTENTIAL DISCREPANCIES WITH HEA BEADCHIP RESULTS AS THE SAMPLE TYPED U- ONCE AND U+ ONCE UPON REPEAT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13111763 ↗MalfunctionDec 8, 2021False Negative Result; False Negative Result
ON (B)(6) 2021 THE CUSTOMER REPORTED TWO POSSIBLE DISCREPANCIES AS THE SAMPLES TYPED FYA- BY HEA AND FYA+ TWICE BY SEROLOGY AND HEA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12965165 ↗
Other Molecular Erythrocyte Typing Test devices
- Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Slides 800-20202-08Bioarray Solutions Ltd · Molecular Erythrocyte Typing Test116 reports
- ID CORE XT v3Progenika Biopharma, SA · Molecular Erythrocyte Typing Test42 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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