cobas® TaqScreen MPX Test, v2.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00875197004045), received between Aug 4, 2021 and May 28, 2026 — classified as 1 injury, 40 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (26 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH THE COBAS® TAQSCREEN MPX TEST, VERSION 2.0 FOR USE ON THE COBAS S 201 SYSTEM WITH A DONOR SAMPLE. THE INITIAL POOLED SAMPLE GENERATED A REACTIVE RESULT FOR HBV. DURING RESOLUTION TESTING, THE SAME SAMPLE GENERATED A NON-REACTIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25315157 ↗
• MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF A QUESTIONABLE HCV RESULT WITH EQA PROFICIENCY SAMPLES TESTED WITH THE COBAS® TAQSCREEN MPX TEST, VERSION 2.0 FOR USE ON THE COBAS S 201 SYSTEM. ON (B)(6) 2026, THE INITIAL PRIMARY POOL OF 6 (PP6) AND PRIMARY POOL OF 1 (PP1) RESULTS WERE NON-REACTIVE. ON (B)(6) 2026, THE RETEST OF PP6 WAS NON-REACTIVE AND THE RETEST OF PP1 WAS REACTIVE FOR HCV. REPEAT ON A COMPETITOR PLATFORM, KEHUA, WITH A PP8 AND PP1 WAS REACTIVE FOR HCV. THE SAMPLE WAS ALSO REPEATED AT ANOTHER CUSTOMER SITE AND THE PP6 WAS NON-REACTIVE AND PP1 WAS REACTIVE FOR HCV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909951 ↗
• MalfunctionFeb 23, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE HBV RESULTS WITH THE COBAS® TAQSCREEN MPX TEST, VERSION 2.0 FOR USE ON THE COBAS S 201 SYSTEM. IT WAS REPORTED THAT THE SAMPLES WERE INITIALLY TESTED REACTIVE FOR HBV BUT WERE NEGATIVE UPON RESOLUTION TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421567 ↗
• MalfunctionFeb 11, 2026False Negative Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE HCV RESULT FOR ONE PATIENT SAMPLE WITH THE COBAS® TAQSCREEN MPX TEST, VERSION 2.0 FOR USE ON THE COBAS S 201 SYSTEM. ON (B)(6) 2025, THE INITIAL POOLED RESULT WAS HCV REACTIVE. ALINITY ABBOTT SEROLOGY RESULTS: REACTIVE FOR HCV (2.1 S/CO), SERUM REPEAT (2.3 S/CO), PLASMA REPEAT (1.77 S/CO). A CONFIRMATORY TEST WAS PERFORMED (INNO-LIA HCV SCORE FUJIREBIO) AND THE RESULTS FOR THIS WERE: POSITIVE 4 BANDS OUT OF 6 (C1 +, C2 +, E2 -, NS3 +, NS4 +, NS5 -). IN (B)(6) 2025, THE DONOR DONATED AT ANOTHER BLOOD BANK (USING ROCHE NAT PLATFORM) AND THE RESULT WAS UNDETECTABLE FOR HCV. ON (B)(6) 2026, THE RECOLLECTED INDIVIDUAL RESULT WAS HCV NON-REACTIVE. ALINITY ABBOTT SEROLOGY RESULTS: REACTIVE FOR HCV (2.17 S/CO).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312532 ↗
• MalfunctionNov 19, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE WITH THE COBAS® TAQSCREEN MPX TEST, VERSION 2.0 FOR USE ON THE COBAS S 201 SYSTEM. THE INITIAL RESULT WAS NON-REACTIVE. THE REPEAT RESULT WAS REACTIVE AFTER RECEIVING TRANSFUSION. SEROLOGY WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23592953 ↗
• MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS FOR HIV AND HBV WHEN USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON A COBAS S201 INSTRUMENT. ON (B)(6)2023, A SAMPLE TESTED IN A POOL OF 6 (PP6) WAS NON-REACTIVE FOR HIV AND REACTIVE FOR HBV WITH A CYCLE THRESHOLD (CT) VALUE OF 35.7. ON (B)(6)2023, THE SAMPLE WAS TESTED USING A COMPETITOR NUCLEIC ACID TESTING (NAT) ASSAY IN A POOL OF 1 (PP1) AND WAS REACTIVE FOR HIV WITH A CT VALUE OF 40.26. ON (B)(6)2023, THE SAMPLE WAS REPEATED IN RESOLUTION (RESP1) AND WAS NON-REACTIVE FOR HIV AND REACTIVE FOR HBV WITH A CT VALUE OF 34.6. SEROLOGY RESULTS FOR THE SAMPLE WERE REACTIVE FOR HIV WITH TWO DIFFERENT SEROLOGY TESTS AND NON-REACTIVE FOR HEPATITIS B SURFACE ANTIGEN (HBSAG). THE BLOOD DONATION ASSOCIATED WITH THE SAMPLE WAS DESTROYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100419 ↗
• MalfunctionSep 19, 2025False Negative Result; False Negative Result

  THE INITIAL REPORTER ALLEGED A FALSE NON-REACTIVE RESULT FOR HEPATITIS B VIRUS (HBV) USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE COBAS TAQMAN INSTRUMENT. A PATIENT SAMPLE WAS INITIALLY TESTED ON 06-JUN-2023, WHERE SEROLOGY RESULTS SHOWED A POSITIVE HEPATITIS B SURFACE ANTIGEN (HBSAG) RESULT OF 2404 AND A POSITIVE ANTI-HEPATITIS B CORE ANTIBODY (ANTI-HBC) RESULT OF 0.09. THE SAMPLE WAS SUBSEQUENTLY TESTED ON THE COBAS TAQMAN INSTRUMENT, YIELDING A REACTIVE RESULT WITH A CYCLE THRESHOLD (CT) VALUE OF 38.3 FOR HBV. ON THE SAME DAY, AN ALIQUOT OF THE SAMPLE WAS SENT TO ANOTHER LAB FOR CONFIRMATION. THE SECOND LAB PROCESSED THE SAMPLE INDIVIDUALLY ON ONE OF ITS FOUR COBAS TAQMAN INSTRUMENTS AND OBTAINED A NON-REACTIVE RESULT. IMUNOLAB DID NOT PERFORM SEROLOGY TESTING. THE ALIQUOT WAS TRANSPORTED REFRIGERATED TO IMUNOLAB. THE SAME TUBE USED FOR SEROLOGY TESTING WAS SENT TO A THIRD LAB FOR ADDITIONAL CONFIRMATION. THE THIRD LAB TESTED THE SAMPLE USING A POOLING METHOD (PP6) AND OBTAINED A NON-REACTIVE RESULT. THE CUSOTMER AND THE SECOND LAB TESTED THE SAMPLE AS INDIVIDUAL DONOR TESTING (IDT), WHILE THE THIRD LAB USED POOLED TESTING. NO RESULTS WERE REPORTED, AND NO HARM WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100359 ↗
• MalfunctionSep 19, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WHEN USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE COBAS TAQMAN INSTRUMENT. ON (B)(6) 2023, A SAMPLE WAS TESTED IN A POOL OF 6 (PP6) AND WAS NON-REACTIVE FOR ALL TARGETS. SEROLOGY TESTING FOR THE SAME SAMPLE WAS REACTIVE FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV). THE SAMPLE WAS SUBSEQUENTLY TESTED IN RESOLUTION (RESP1) AND WAS REACTIVE FOR HIV WITH A CYCLE THRESHOLD (CT) VALUE OF 38. THE SAMPLE WAS LATER TESTED WITH A QUANTITATIVE ASSAY, WHICH DETECTED A LOW CONCENTRATION OF VIRAL TARGET WITH A VALUE OF LESS THAN 20 COPIES PER MILLILITER (CP/ML). THE DONATION WAS BLOOD, AND IT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100336 ↗
• MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS FOR HEPATITIS B VIRUS (HBV) TESTING USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY. ON (B)(6) 2022, THE CUSTOMER TESTED A POOL OF 6 SAMPLES ON AN S201 SYSTEM, WHICH GENERATED A REACTIVE RESULT FOR HBV WITH A CYCLE THRESHOLD (CT) VALUE OF 37.6. HOWEVER, THE RESULT COULD NOT BE TRANSMITTED TO THE DATABASE DUE TO A DATA TRANSMISSION ISSUE. ON (B)(6) 2022, THE CUSTOMER REPEATED THE POOL OF 6 SAMPLES ON ANOTHER S201 SYSTEM, AND THE RESULT WAS NON-REACTIVE. ON (B)(6) 2022, THE CUSTOMER TESTED AN INDIVIDUAL DONOR SAMPLE FROM THE REACTIVE POOL ON (B)(6) 2022, AND THE RESULT WAS HBV REACTIVE. THE BLOOD DONATION WAS NOT USED. ON (B)(6) 2022, THE CUSTOMER PERFORMED ADDITIONAL TESTING ON THE PLASMA FROM THE PLASMA BAG OF THE SAME DONOR SAMPLE, WHICH WAS AGAIN HBV REACTIVE. THE CT VALUES FOR THE INDIVIDUAL DONOR SAMPLE WERE 33.5 AND 35.2 IN REPEATED TESTS. THE GROWTH CURVES FOR ALL REACTIVE RESULTS WERE ROBUST AND SIGMOIDAL, INDICATING AMPLIFICATION OF TRUE VIRAL TARGETS. POSITIVE AND NEGATIVE CONTROLS WERE ALSO ROBUST AND SIGMOIDAL, CONFIRMING THAT THE ASSAY WAS FUNCTIONING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099981 ↗
• MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE COBAS TAQMAN INSTRUMENT. THE ALLEGATION INVOLVED REACTIVE RESULTS IN POOLS FOR HEPATITIS C VIRUS (HCV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) THAT RESOLVED TO NON-REACTIVE RESULTS DURING RESOLUTION TESTING. THE REACTIVE POOL RESULTS WERE CONSIDERED INTERIM RESULTS, AND THE RESOLUTION TESTING RESULTS WERE CONSIDERED FINAL. SEROLOGY TESTING FOR THE SAMPLES IN QUESTION WAS NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099639 ↗
• MalfunctionSep 19, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED A FALSE REACTIVE RESULT FOR HEPATITIS B VIRUS (HBV) WHEN USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE S201 INSTRUMENT. THE CUSTOMER WORKFLOW INVOLVED TESTING A PRIMARY POOL OF 6 (PP6) SAMPLES. ON (B)(6) 2024, THE PP6 GENERATED A REACTIVE RESULT WITH A CYCLE THRESHOLD (CT) VALUE OF 36.9. THE CUSTOMER REPEATED THE RESOLUTION TESTING, AND ALL SIX INDIVIDUAL SAMPLES WERE NON-REACTIVE. SUBSEQUENTLY, THE CUSTOMER RETESTED ALL SAMPLES FROM THE SAME ALIQUOT AT THE INDIVIDUAL SAMPLE LEVEL (PP1), AND ONE SAMPLE GENERATED A REACTIVE RESULT WITH A CT VALUE OF 36.5. NO HARM WAS ALLEGED, AND THE ASSOCIATED BLOOD BAG WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099607 ↗
• MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED A DECREASE IN THE HEPATITIS B VIRUS (HBV) POSITIVE RATE WHEN USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE COBAS TAQMAN INSTRUMENT. THE CUSTOMER REPORTED THAT IN 2021, THEY TESTED (B)(4) DONOR SAMPLES USING THE MPXV2.0 ASSAY IN PP6 MODE AND OBSERVED 25 HBV POSITIVE RESULTS OUT OF 38 POSITIVE POOLS, WHICH WAS COMPARABLE TO THE RESULTS OBTAINED WITH THE CE VERSION OF THE ASSAY. FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV), NO POSITIVE RESULTS WERE OBSERVED OUT OF 4 POSITIVE POOLS, AND FOR HEPATITIS C VIRUS (HCV), 1 POSITIVE RESULT WAS OBSERVED OUT OF 13 POSITIVE POOLS. THESE RESULTS WERE ALSO COMPARABLE TO THOSE OBTAINED WITH A COMPETITOR ASSAY. IN 2022, THE CUSTOMER TESTED 14,385 DONOR SAMPLES USING THE MPXV2.0 ASSAY AND OBSERVED 3 HBV POSITIVE RESULTS OUT OF 9 POSITIVE POOLS, 1 HIV POSITIVE RESULT OUT OF 3 POSITIVE POOLS, AND NO HCV POSITIVE POOLS. DURING THE SAME PERIOD, THE COMPETITOR ASSAY DETECTED 16 HBV POSITIVE RESULTS OUT OF 18 POSITIVE POOLS AND 1 HIV POSITIVE RESULT OUT OF 3 POSITIVE POOLS IN 21,796 DONATIONS. THE HBV POSITIVE RATE APPEARED TO BE LOWER WITH THE MPXV2.0 ASSAY ON THE COBAS TAQMAN INSTRUMENT COMPARED TO THE COMPETITOR ASSAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099593 ↗
• MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS BETWEEN POOL TESTING AND RESOLUTION TESTING USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ON THE COBAS TAQMAN INSTRUMENT. ON (B)(6) 2021, A POOL OF 6 SAMPLES WAS REACTIVE FOR HEPATITIS C VIRUS (HCV) WITH A CYCLE THRESHOLD (CT) VALUE OF 45.9. RESOLUTION TESTING OF ONE SAMPLE FROM THIS POOL WAS REACTIVE FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV) WITH A CT VALUE OF 39.5. REPEAT TESTING OF THIS SAMPLE WAS NON-REACTIVE. SEROLOGY FOR THIS SAMPLE WAS NON-REACTIVE. ON THE SAME DATE, A DIFFERENT POOL OF 6 SAMPLES WAS REACTIVE FOR HCV WITH A CT VALUE OF 50.5. RESOLUTION TESTING OF ONE SAMPLE FROM THIS POOL WAS REACTIVE FOR HEPATITIS B VIRUS (HBV) WITH A CT VALUE OF 35.5. REPEAT TESTING OF THIS SAMPLE WAS REACTIVE FOR HBV WITH A CT VALUE OF 35.1. SEROLOGY FOR THIS SAMPLE WAS NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099288 ↗
• MalfunctionSep 19, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE INITIAL REPORTER ALLEGED FALSE REACTIVE RESULTS WHILE USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE STAR INSTRUMENT. THE ALLEGATION INVOLVED THREE POOLED SAMPLES GENERATING FALSE REACTIVE HIV RESULTS AND EIGHT POOLED SAMPLES GENERATING FALSE REACTIVE HEPATITIS C VIRUS (HCV) RESULTS. DATA PROVIDED BY THE CUSTOMER INCLUDED ONE SPECIFIC HCV SAMPLE (BARCODE (B)(4)), WHICH GENERATED A REACTIVE RESULT WITH A CYCLE THRESHOLD (CT) VALUE OF 41.02 ON (B)(6) 2021. NO ADDITIONAL SAMPLE-SPECIFIC DATA WAS PROVIDED. THE RESULTS WERE NOT FURTHER RESOLVED TO INDIVIDUAL DONOR SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099053 ↗
• MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WITH THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ON THE COBAS TAQMAN INSTRUMENT. THE CUSTOMER, A CORD BLOOD CENTER, REPORTED THAT A POOLED SAMPLE GENERATED A REACTIVE RESULT. UPON RESOLUTION TESTING, INDIVIDUAL DONOR SAMPLES FROM THE POOL GENERATED NON-REACTIVE RESULTS. SEROLOGY TESTING FOR ALL INDIVIDUAL DONOR SAMPLES WAS CONFIRMED TO BE NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098315 ↗
• MalfunctionSep 19, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE INITIAL REPORTER ALLEGED FALSE REACTIVE HIV RESULTS FOR TWO SAMPLES TESTED USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE COBAS S201 INSTRUMENT. ON (B)(6) 2021, SAMPLE BARCODE (B)(4) WAS REPORTED AS REACTIVE FOR HIV WITH A CYCLE THRESHOLD (CT) VALUE OF 43.06. ON (B)(6) 2021, SAMPLE BARCODE (B)(4) WAS REPORTED AS REACTIVE FOR HIV WITH A CT VALUE OF 34.4. SEROLOGY TESTING FOR BOTH DONOR SAMPLES WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098191 ↗
• MalfunctionSep 19, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WITH THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE COBAS TAQMAN INSTRUMENT. THE ALLEGATION INVOLVED A POOL OF 6 SAMPLES THAT GENERATED A REACTIVE RESULT FOR HIV WITH A CYCLE THRESHOLD (CT) VALUE OF 42.6. THE CUSTOMER NOTED THAT THE GROWTH CURVE DISPLAYED IN THE AMPLILINK SOFTWARE WAS UNCLEAR. WHEN THE SAMPLE IN QUESTION WAS TESTED IN A RESOLUTION POOL OF 1, A NON-REACTIVE RESULT WAS GENERATED. THE CUSTOMER SUBSEQUENTLY RETESTED THE SAME SAMPLE AND OBTAINED ANOTHER NON-REACTIVE RESULT. THE DONATION ASSOCIATED WITH THE SAMPLE WAS RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098181 ↗
• MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WERE GENERATED USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE S201 INSTRUMENT. THE SAMPLE IN QUESTION WAS NON-REACTIVE FOR HEPATITIS C VIRUS (HCV) WHEN TESTED ON THE S201 INSTRUMENT. HOWEVER, THE SAME SAMPLE WAS REACTIVE FOR HCV WITH A CYCLE THRESHOLD (CT) VALUE OF 40.34 WHEN TESTED ON THE COBAS 8800 SYSTEM. ADDITIONALLY, THE SAMPLE TESTED POSITIVE FOR HCV SEROLOGY. THE ORGAN ASSOCIATED WITH THE DONOR SAMPLE WAS DISCARDED, AND ORGAN/TISSUE DONATION DID NOT PROCEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097856 ↗
• MalfunctionSep 19, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WITH THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE COBAS S201 INSTRUMENT. ON (B)(6) 2020, A SAMPLE TESTED REACTIVE FOR HEPATITIS C VIRUS (HCV) WITH A CYCLE THRESHOLD (CT) VALUE OF 42.9. ON 03-JUL-2020, THE SAME SAMPLE WAS REPEATED AND WAS NON-REACTIVE FOR ALL TARGETS. SEROLOGY TESTING FOR THE SAMPLE WAS ALSO NON-REACTIVE. ORGANS WERE NOT RECOVERED FOR DONATION; HOWEVER, THIS DECISION WAS NOT ATTRIBUTED TO THE REACTIVE RESULT OF THE MPX TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096941 ↗
• MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ON THE COBAS AMPLIPREP INSTRUMENT. THE CUSTOMER REPORTED THAT A PP6 SAMPLE GENERATED A HEPATITIS B VIRUS (HBV) REACTIVE RESULT WITH A CYCLE THRESHOLD (CT) VALUE OF 36.0. UPON RESOLUTION TESTING, THE SAME SAMPLE GENERATED A HEPATITIS C VIRUS (HCV) REACTIVE RESULT WITH A CT VALUE OF 43.0. A SUBSEQUENT RE-TEST OF THE SAMPLE GENERATED NON-REACTIVE RESULTS. SEROLOGY TESTING FOR THE SAMPLE WAS NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095384 ↗
• MalfunctionSep 19, 2025False Negative Result; False Negative Result

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS FOR THE HBV TARGET USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE COBAS S201 INSTRUMENT. THE CUSTOMER ALSO REPORTED A YEAR-OVER-YEAR DECLINE IN HBV POSITIVE RATES FROM 2020 TO 2023, RAISING CONCERNS ABOUT POTENTIAL FALSE NEGATIVE RESULTS. THE CUSTOMER CONDUCTED A LIMIT OF DETECTION (LOD) TEST FOR HIV, HBV, AND HCV TARGETS USING EXTERNAL MATERIAL FROM AN UNKNOWN THIRD-PARTY SUPPLIER. THE MATERIAL WAS DILUTED TO 1XLOD FOR EACH TARGET, WITH THE HBV TARGET SHOWING DISCREPANCIES. SPECIFICALLY, FOR THE FIRST BATCH OF TESTING, TWO SAMPLES ((B)(6)) WERE UNEXPECTEDLY NEGATIVE. THE EXTERNAL MATERIAL HAD A PRIMARY CONCENTRATION OF 50 IU/ML AND WAS DILUTED TO 2.5 IU/ML, WHICH IS NEAR THE ASSAY'S LOD OF 2.3 IU/ML. THE CUSTOMER NOTED THAT FOR LOD TESTING, THE VALIDITY CRITERIA REQUIRE 18 OUT OF 20 POOLS TO BE POSITIVE. THE CUSTOMER OBSERVED VARIATION IN HBV CYCLE THRESHOLD (CT) VALUES DURING THE FIRST BATCH OF TESTING, WITH VALUES RANGING FROM 35.7 TO 38.5, WHICH COINCIDED WITH THE FALSE NEGATIVE RESULTS. IN CONTRAST, THE SECOND BATCH OF TESTING SHOWED CONSISTENT CT VALUES WITH NO FALSE NEGATIVE RESULTS. THE INTERNAL CONTROLS AND QUALIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094362 ↗
• MalfunctionSep 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WHEN USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE COBAS TAQMAN INSTRUMENT. THE EVENT INVOLVED A POOL OF 6 SAMPLES INITIALLY TESTED ON (B)(6) 2022, WHICH GENERATED A REACTIVE RESULT FOR HEPATITIS C VIRUS (HCV) WITH A CYCLE THRESHOLD (CT) VALUE OF 44.2. THE POOL WAS RETESTED ON THE SAME DAY AND GENERATED A NON-REACTIVE RESULT FOR HCV BUT A REACTIVE RESULT FOR HEPATITIS B VIRUS (HBV) WITH A CT VALUE OF 4.9. SEROLOGY TESTING FOR BOTH HCV AND HBV WAS NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088668 ↗
• MalfunctionSep 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WHEN USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE COBAS S201 INSTRUMENT. THE CUSTOMER WAS CONDUCTING A VALIDATION STUDY COMPARING THE CE-IVD VERSION OF THE ASSAY TO THE US-IVD VERSION OF THE ASSAY. ON (B)(6) 2021, 60 SAMPLES WERE TESTED WITH THE CE-IVD VERSION, AND ALL WERE NON-REACTIVE FOR HIV, HEPATITIS B VIRUS (HBV), AND HEPATITIS C VIRUS (HCV). ON (B)(6) 2021, THE SAME 60 SAMPLES WERE TESTED WITH THE US-IVD VERSION, AND ONE SAMPLE WAS REACTIVE FOR HIV, HBV, AND HCV, WITH CYCLE THRESHOLD (CT) VALUES OF 35.8, 36.7, AND 40.3, RESPECTIVELY. SEROLOGY TESTING FOR THIS SAMPLE AND ALL OTHER SAMPLES WAS NON-REACTIVE FOR ALL THREE TARGETS. THE BLOOD DONATION WAS NOT RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086528 ↗
• MalfunctionSep 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED AN UNEXPECTED REACTIVE RESULT FOR HEPATITIS B VIRUS (HBV) WHEN USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE COBAS AMPLIPREP INSTRUMENT. A PLASMA SAMPLE FOR BLOOD DONATION WAS TESTED AS AN INDIVIDUAL DONATION TEST (IDT) AND GENERATED A REACTIVE HBV RESULT WITH A CYCLE THRESHOLD (CT) VALUE OF 36.9. REPEAT TESTING FROM THE SAME TUBE WAS NON-REACTIVE. A NEW SAMPLE FROM THE SAME DONOR WAS TESTED AND WAS ALSO NON-REACTIVE. SEROLOGY RESULTS FOR THE SAMPLE WERE NOT PROVIDED. THE DONATION BAG ASSOCIATED WITH THE SAMPLE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085560 ↗
• MalfunctionSep 18, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE INITIAL REPORTER ALLEGED AN INCREASE IN UNEXPECTED HEPATITIS C VIRUS (HCV) REACTIVE RESULTS AFTER SWITCHING FROM THE CE-IVD VERSION TO THE US-IVD VERSION OF THE KIT S201 T-SCRN MPX V2.0 96T ASSAY ON THE CONTROL UNIT BLOOD SCREENING S201 INSTRUMENT. THE CUSTOMER PROVIDED DATA SHOWING QUESTIONABLE HCV POSITIVE RESULTS USING THE MPX V2.0 US-IVD TEST. IT WAS NOTED THAT WEAK SPIKES IN THE GROWTH CURVES DISPLAYED IN THE AMPLILINK SOFTWARE WERE OBSERVED. THESE CURVES, WHICH ARE VISIBLE PRIOR TO THE APPLICATION OF THE ALGORITHM, WERE ULTIMATELY DETERMINED TO BE NON-REACTIVE AFTER THE ALGORITHM WAS APPLIED, AS INDICATED BY THE PDM (POST-DETECTION MODULE) RESULT. NO HARM WAS ALLEGED, AND THE QUESTIONED POSITIVE RESULTS DID NOT LEAD TO ANY ORGAN DONATION REJECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083418 ↗