ID CORE XT v3Recalls & reported problems
Progenika Biopharma, SA · ID CORE XT (Reagents and Analysis Software) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms and predict 37 HEA phenotypes of blood group systems Rh (CW, C, c, E, e, VS, V, hrB, hrS), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Kidd (Jka, Jkb), Duffy (Fya, Fyb), MNS (M, N, S, s, U, Mia), Diego (Dia, Dib), Dombrock (Doa, Dob, Hy, Joa), Colton (Coa, Cob), Cartwright (Yta, Ytb), and Lutheran (Lua, Lub) as an alternative to serology. The ID CORE XT test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. ID CORE XT generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is a polymorphism genotype, a predicted allele genotype and a predicted phenotype, bypassing any subjective interpretation of the results. · Class 3
Quick summary
This Progenika ID CORE XT is a lab test that uses DNA analysis to determine a patient's blood group types as an alternative to traditional blood testing. There are 42 adverse event reports naming its identifier, with no deaths and no injuries; nearly all describe the molecular test giving results that disagreed with standard serology testing, such as false positive or false negative antigen readings. 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
- 42
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 08437013457019), received between Feb 21, 2020 and Jun 27, 2025 — classified as 42 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (25 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- False Positive Result25
- Incorrect, Inadequate or Imprecise Result or Readings13
- False Negative Result12
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- No Consequences Or Impact To Patient6
- Patient Problem/Medical Problem2
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT THE SAMPLE (B)(6) WAS TESTED WITH SEROLOGY. THE TEST RESULT WAS NEGATIVE (E-), WHICH CONTRASTED WITH MOLECULAR TYPING PERFORMED ON (B)(6) 2025 BY "GRIFOLS LABORATORY SOLUTIONS", USING THE ID CORE XT ASSAY. THE MOLECULAR TYPING PROVIDED A POSITIVE RESULT (E+) WITH ID CORE XT ANALYSIS SOFTWARE V3.0.5..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22343873 ↗MalfunctionJun 27, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT THE SAMPLE (B)(6) WAS TESTED WITH SEROLOGY. THE TEST RESULT WAS NEGATIVE (C-), WHICH CONTRASTED WITH MOLECULAR TYPING PERFORMED ON (B)(6) 2025 BY "GRIFOLS LABORATORY SOLUTIONS", USING THE ID CORE XT ASSAY. THE MOLECULAR TYPING PROVIDED A POSITIVE RESULT (C+) WITH ID CORE XT ANALYSIS SOFTWARE V3.0.5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22343863 ↗MalfunctionMar 31, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT THE SAMPLE (B)(6) FROM "MAYO CLINIC RECEIVING HUB" WAS TESTED WITH SEROLOGY. THE TEST RESULT WAS JKB POSITIVE (JKB+) WHICH CONTRASTED WITH THE MOLECULAR TYPING PERFORMED WITH ID CORE XT ON (B)(6) 2025, WHICH PROVIDED JKB NEGATIVE (JKB-) RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21729293 ↗MalfunctionFeb 19, 2025False Negative Result; False Negative Result
IT WAS REPORTED THAT THE SAMPLE (B)(6) FROM "(B)(6)" WAS TESTED WITH SEROLOGY. THE TEST RESULT WAS POSITIVE (S+) WHICH CONTRASTED WITH THE MOLECULAR TYPING PERFORMED ON (B)(6) 2024 AND ON (B)(6) 2025, USING THE ID CORE XT ASSAY WHICH PROVIDED NEGATIVE RESULTS (S-) WITH ID CORE XT ANALYSIS SOFTWARE V3.0.5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21408693 ↗MalfunctionJan 5, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT THE SAMPLE (B)(6), FROM "LIFESOUTH COMMUNITY BLOOD CENTER" WAS TESTED WITH SEROLOGY. THE TEST RESULT WAS NEGATIVE (S-), WHICH CONTRASTED WITH THE MOLECULAR TYPING PERFORMED ON (B)(6) 2024, USING THE ID CORE XT ASSAY WHICH PROVIDED POSITIVE RESULTS (S+), WITH ID CORE XT ANALYSIS SOFTWARE V3.0.5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21075935 ↗MalfunctionOct 5, 2024False Negative Result; False Negative Result
IT WAS REPORTED BY "GRIFOLS LABORATORY SOLUTIONS" THAT PATIENT SAMPLE 8735 WAS TESTED USING ID CORE XT. THE INITIAL TEST RESULT INDICATED AN INDETERMINATE CARTWRIGHT GENOTYPE, AND A SUBSEQUENT ID CORE XT TEST SHOWED A NEGATIVE RESULT FOR YTA (YTA-). HOWEVER, DUE TO AN UNUSUAL AND ALTERED SIGNAL RATIOS OF CARTWRIGHT PROBES, YT (ACHE) EXONS 1 TO 6 WAS SEQUENCED. THE NGS SEQUENCING REVEALED A POSITIVE RESULT (YTA+) WHICH CONTRASTED WITH THE ID CORE XT TYPING
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20378813 ↗MalfunctionOct 5, 2024False Negative Result; False Negative Result
IT WAS REPORTED FROM "LIFESOUTH COMMUNITY BLOOD CENTER" THAT TWO SAMPLES (B)(6) FROM THE SAME PATIENT WERE TESTED USING ID CORE XT ASSAY. THE MIA RESULTS OF THESE TESTS WERE DISCREPANT. ONE TEST PERFORMED ON (B)(6) 2023 WITH SAMPLE (B)(6) SHOWED A NEGATIVE RESULT FOR MIA (MIA-) WHILE THE OTHER TEST CONDUCTED ON 21AUG24 WITH SAMPLE (B)(6) SHOWED A POSITIVE RESULT (MIA+). IN BOTH CASES, THE MIA PROBE RATIO EXHIBITED AN UNUSUAL AND ALTERED SIGNAL RATIOS. ALL GENOTYPE AND PHENOTYPE RESULTS WERE PROVIDED BY THE ID CORE XT ANALYSIS SOFTWARE V3.0.5.1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20378811 ↗MalfunctionJun 10, 2024False Negative Result; False Negative Result
IT WAS REPORTED THAT THE SAMPLE (B)(6) FROM "LIFESOUTH COMMUNITY BLOOD CENTER", WAS TESTED WITH SEROLOGY. THE TEST RESULT WAS POSITIVE (M+), WHICH CONTRASTED WITH TWO MOLECULAR TYPING PERFORMED ON (B)(6) 2024 AND (B)(6) 2024, USING THE ID CORE XT ASSAY WHICH PROVIDED NEGATIVE RESULTS (M-) WITH ID CORE XT ANALYSIS SOFTWARE V3.0.5.12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19497700 ↗MalfunctionDec 28, 2023False Positive Result; False Positive Result
IT WAS REPORTED THAT THE SAMPLE W051523064512, FROM MEMORIAL BLOOD CENTER, WAS TESTED WITH SEROLOGY PROVIDING A NEGATIVE RESULT (K-), WHICH CONTRASTED WITH THE MOLECULAR TYPING PERFORMED ON 30NOV23 USING THE ID CORE XT ASSAY WHICH PROVIDED POSITIVE RESULTS (K+) WITH ID CORE XT ANALYSIS SOFTWARE V3.0.4.1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18413957 ↗MalfunctionOct 2, 2023False Negative Result; False Negative Result
IT WAS REPORTED THAT THE SAMPLE (B)(6), FROM "MEMORIAL BLOOD CENTER", WAS TESTED WITH SEROLOGY. THE TEST RESULT WAS POSITIVE (C+), WHICH CONTRASTED WITH THE MOLECULAR TYPING PERFORMED ON (B)(6) 2023, USING THE ID CORE XT ASSAY WHICH PROVIDED NEGATIVE RESULTS (C-), WITH ID CORE XT ANALYSIS SOFTWARE V3.0.4.1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17849775 ↗MalfunctionJun 9, 2023False Positive Result; False Positive Result
IT WAS REPORTED THAT THE SAMPLE GDS-23-01340, FROM "GRIFOLS LABORATORY SOLUTIONS", WAS TESTED WITH SEROLOGY. THE TEST RESULT WAS C-, WHICH CONTRASTED WITH MOLECULAR TYPING PERFORMED ON (B)(6)2023, USING THE ID CORE XT ASSAY WHICH PROVIDED C+, WITH ID CORE XT ANALYSIS SOFTWARE V3.0.5. THE LOT OF ID CORE XT USED WAS LOT 0203000027.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17096910 ↗MalfunctionJun 9, 2023False Negative Result; False Negative Result
IT WAS REPORTED THAT THE SAMPLE (B)(6). FROM "MEMORIAL BLOOD CENTER", WAS TESTED WITH SEROLOGY. THE TEST RESULT WAS POSITIVE (C+), WHICH CONTRASTED WITH THE MOLECULAR TYPING PERFORMED ON (B)(6) 2023, USING THE ID CORE XT ASSAY WHICH PROVIDED NEGATIVE RESULTS (C-), WITH ID CORE XT ANALYSIS SOFTWARE V3.0.4.1. THE LOT OF ID CORE XT USED WAS LOT 0203000028.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17096909 ↗MalfunctionMar 17, 2023False Positive Result; False Positive Result
THE CUSTOMER REPORTED A MALFUNCTION. ID CORE XT PHENOTYPE RESULT WAS JKB+ AND SEROLOGICAL RESULT WAS JKB-.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16565755 ↗MalfunctionMar 17, 2023False Positive Result; False Positive Result
THE CUSTOMER REPORTED A MALFUNCTION. ID CORE XT PHENOTYPE RESULT WASJKB+ AND SEROLOGICAL RESULT WAS JKB-.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16565742 ↗MalfunctionFeb 23, 2023False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
THE SAMPLE CODED AS (B)(4) WERE TESTED BY THE CUSTOMER "(B)(6) CENTER" WITH ID CORE XT ASSAY. THE RESULT OF THE FIRST MOLECULAR TYPING PERFORMED ON (B)(6) 2023 WITH ID CORE XT LOT 0203000026 WAS POSITIVE (LUA+), WHICH WAS IN CONTRAST TO THE RESULT OF MOLECULAR TYPING PERFORMED ON 18JAN2023, USING THE ID CORE XT ASSAY LOT 0203000026 WHICH PROVIDED A NEGATIVE RESULT (LUA-). ALL GENOTYPE AND PHENOTYPE RESULTS WERE PROVIDED BY THE ID CORE XT ANALYSIS SOFTWARE V3.0.5.12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16432891 ↗MalfunctionFeb 20, 2023False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
THE SAMPLES CODED AS (B)(6) WERE TESTED BY THE CUSTOMER "LIFESOUTH COMMUNITY BLOOD CENTER" WITH ID CORE XT ASSAY. BOTH SAMPLES CAME FROM THE SAME DONOR, BUT FROM TWO DIFFERENT DNA EXTRACTION EVENTS. THE RESULT OF THE FIRST MOLECULAR TYPING PERFORMED ON (B)(6) 2022 WITH SAMPLE (B)(6) AND ID CORE XT LOT 0203000026 WAS POSITIVE (LUA+), WHICH WAS IN CONTRAST TO THE RESULT OF MOLECULAR TYPING PERFORMED ON 11JAN2023, USING THE ID CORE XT ASSAY LOT 0203000026 WITH SAMPLE (B)(6) WHICH PROVIDED A NEGATIVE RESULT (LUA-). ALL GENOTYPE AND PHENOTYPE RESULTS WERE PROVIDED BY THE ID CORE XT ANALYSIS SOFTWARE V3.0.4.1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16403307 ↗MalfunctionJan 26, 2023False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A MALFUNCTION OF ID CORE XT. THE SAMPLE (B)(6) ANALYZED (WORK ORDER (B)(4)) ON 13OCT2022 USING THE ID CORE XT PROVIDED A POSITIVE RESULT (LUA+). HOWEVER, THIS RESULT WAS DIFFERENT TO OTHER SAMPLE FROM THE SAME DONOR ((B)(6)), ANALYZED ON 25MAY2022 THAT RESULTED NEGATIVE (LUA-).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16250547 ↗MalfunctionJan 26, 2023False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
THE SAMPLES CODED AS (B)(6) WERE TESTED BY THE CUSTOMER "(B)(6) CENTER" WITH ID CORE XT ASSAY. BOTH SAMPLES CAME FROM THE SAME DONOR, BUT FROM TWO DIFFERENT DNA EXTRACTION EVENTS. THE RESULT OF THE FIRST MOLECULAR TYPING PERFORMED ON (B)(6) 2022 WITH SAMPLE (B)(6) AND ID CORE XT LOT 0203000024 WAS NEGATIVE (LUA), WHICH WAS IN CONTRAST TO THE RESULT OF MOLECULAR TYPING PERFORMED ON (B)(6) 2022, USING THE ID CORE XT ASSAY LOT 0203000026 WITH SAMPLE (B)(6) WHICH PROVIDED A POSITIVE RESULT (LUA+). ALL GENOTYPE AND PHENOTYPE RESULTS WERE PROVIDED BY THE ID CORE XT ANALYSIS SOFTWARE V3.0.4.1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16250532 ↗MalfunctionDec 29, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE TEST RESULT WAS NEGATIVE (K MINOR-) WITH SEROLOGY, WHICH WAS IN CONTRAST TO MOLECULAR TYPING OF THE SAME SAMPLE PERFORMED ON (B)(6) 2022, USING THE ID CORE XT ASSAY WHICH PROVIDED POSITIVE RESULTS (K MINOR+).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16073298 ↗MalfunctionOct 31, 2022False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information
THE CUSTOMER REPORTED A MALFUNCTION OF ID CORE XT. SAMPLE ORIGINALLY TESTED AS LUA NEGATIVE, TESTED AS LUA POSITIVE AND THE REPETITION TESTED WITH DIFFERENT PRODUCT BATCH AS LUA NEGATIVE. NO SEROLOGICAL TESTING WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15698703 ↗MalfunctionOct 17, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED A MALFUNCTION OF ID CORE XT. K (MINOR) DISCREPANCY BETWEEN ID CORE XT (POSITIVE) AND SEROLOGICAL (NEGATIVE) RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15613373 ↗MalfunctionSep 28, 2022False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A MALFUNCTION OF ID CORE XT. ORIGINALLY TESTED DONOR SAMPLE ON (B)(6) 2021 RESULT PHENOTYPE WAS LUA POSITIVE. A NEW SAMPLE TESTED ON (B)(6) 2022 WAS LUA NEGATIVE. THE SITE DID NOT PERFORM ANY SEROLOGICAL TESTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15498764 ↗MalfunctionAug 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED A MALFUNCTION OF ID CORE XT. PHENOTYPE WITH OTHER REFERENCED PRODUCTS RESUTLED OMOZYGOUS BIG C; ID CORE XT RESULT IN HETEROZYGOUS BIG C LITTLE C WITH ID CORE XT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15279768 ↗MalfunctionJul 29, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED A MALFUNCTION OF ID CORE XT. SEROLOGY PHENOTYPE K(-); ID CORE XT PHENOTYPE:K(+).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15133329 ↗MalfunctionMar 10, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED A MALFUNCTION OF ID CORE XT. SEROLOGY PHENOTYPE JKA(-); ID CORE XT PHENOTIPE:JKA(+)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13724373 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.