cobas® HIV-1 09040803190Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00875197006407), received between Mar 8, 2024 and Sep 30, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (14 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946537 ↗
• MalfunctionSep 24, 2026Non Reproducible Results

  There was an allegation of questionable cobas® HIV-1 (192T) results with 3 patient samples tested on the cobas 6800 analyzer.It was reported that the customer was performing a Lot to Lot comparison and repeated 3 samples that were initially tested with a previous lot, N09424, and then with Lot P03576. Sample 1:On (b)(6) 2026, the initial result was 9.21E+01 IU/mL using lot N09424.On (b)(6) 2026, the repeat result was 2.17E+01 IU/mL using lot P03576On (b)(6) 2026, the repeat result was 2.74E+01 IU/mL using lot P03576.Sample 2:On (b)(6) 2026, the initial result was 3.86E+01 IU/mL using Lot N09424.On (b)(6) 2026, the repeat result was negative using lot P03576.Sample 3:On (b)(6) 2026, the initial result was negative using lot N09424.On (b)(6) 2026, the repeat result was negative using lot P03576.On (b)(6) 2026, the repeat result was <Titer min (<20 IU/mL) using lot P03576.The results generated with lot N09242 were deemed correct.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882035 ↗
• MalfunctionSep 3, 2026False Negative Result; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50586075 ↗
• MalfunctionJun 1, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE COBAS® HIV-1 ASSAY RESULTS FOR A PATIENT SAMPLE TESTED ON THE COBAS 5800 ANALYZER. THE INITIAL RESULT WAS 2.00E+003 IU/ML. ON (B)(6) 2026, THE SAMPLE WAS RETESTED AFTER CENTRIFUGATION, YIELDING A TARGET NOT DETECTED (TND) RESULT; WITHOUT FURTHER CENTRIFUGATION, IT YIELDED A RESULT OF 1.11E+004 IU/ML. THE TEST WAS REPEATED AS THE CLINICIAN EXPECTED A TND RESULT BASED ON THERAPEUTIC STATUS. A NEW SAMPLE WAS OBTAINED FROM THE PATIENT, AND THE FOLLOWING RESULTS WERE GENERATED: ON (B)(6) 2026, THE INITIAL RESULT WAS <3.33 X 10^1 IU/ML. ON (B)(6) 2026, THE REPEAT RESULT WAS TND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25355449 ↗
• MalfunctionApr 1, 2026Computer Operating System Problem; Installation-Related Problem

  THERE WAS AN ALLEGATION OF DISCREPANCY IN THE RESULTS BETWEEN THE COBAS 5800 ANALYZER AND THE CUSTOMER'S LIS WITH THE COBAS® HIV-1 (192T) ASSAY. IT WAS ALLEGED THAT RESULTS WITH <20 CP/ML OR >TITER MAX ARE SHOWN IN THE CUSTOMER LIS AS TND (NON-DETECTED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24752526 ↗
• MalfunctionJan 6, 2026False Positive Result; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE-POSITIVE COBAS® HIV-1 (192T) RESULTS FROM THE COBAS 8800. THREE PATIENT TEST SAMPLES RESULTED AS POSITIVE FOR HIV. THESE SAMPLES WERE LATER TESTED ON DECEMBER 09, 2025. TWO OF THE SAMPLES RESULTED AS "TARGET NOT DETECTED". ONE SAMPLE RESULT WAS "TITER MIN". THE REPEAT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23972002 ↗
• MalfunctionDec 18, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE COBAS® HIV-1 (192T) RESULTS WITH THREE PATIENT SAMPLES TESTED ON A COBAS 5800 ANALYZER. SAMPLE 1: THE INITIAL RESULT WAS 586.7 CP/ML. THE FIRST REPEAT RESULT WAS 26.5 CP/ML. (B)(6) 2025; THE SECOND REPEAT RESULT WAS 76.07 CP/ML. SAMPLE 2: THE INITIAL RESULT WAS 1898 CP/ML. THE FIRST REPEAT RESULT WAS 24.1 CP/ML. (B)(6) 2025; THE SECOND REPEAT RESULT WAS <TITER MIN. SAMPLE 3: THE INITIAL RESULT WAS 7343 CP/ML. THE FIRST REPEAT RESULT WAS 34.03 CP/ML. (B)(6) 2025; THE SECOND REPEAT RESULT WAS TARGET NOT DETECTED (TND).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838842 ↗
• MalfunctionNov 25, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF DISCREPANT COBAS® HIV-1 (192T) RESULTS FROM THE COBAS 8800 ANALYZER FOR A SINGLE PATIENT. THE INITIAL SAMPLE WAS GENERATED A POSITIVE HIV RESULT 3 TIMES ON THE COBAS 8800 WITH THE FOLLOWING RESULTS: ON (B)(6) 2025, TITER 3.74E2 (LOG 2.57), ON (B)(6) 2025, TITER 2.68E4 (LOG 4.43), ON (B)(6) 2025, TITER 1.14E4 (LOG 4.06). A DIFFERENT SPECIMEN ON THE SAME DAY WAS TESTED AT ANOTHER SITE FOR HIV GENOTYPE AND HIV VIRAL LOADS (2.04 E4 CPS/ML / LOG 4.31).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647007 ↗
• MalfunctionNov 25, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF DISCREPANT COBAS® HIV-1 (192T) RESULTS FROM THE COBAS 6800 ANALYZER FOR A SINGLE PATIENT. ON (B)(6), THE INITIAL SAMPLE WAS GENERATED A POSITIVE HIV RESULT (TITER 36.1CP/ML ;(B)(6) 2025). SEROLOGY FOR THE SAME SAMPLE GENERATED A NEGATIVE RESULT ON TWO DIFFERENT C8000 INSTRUMENTS. ON (B)(6), THE SAME SAMPLE GENERATED A NEGATIVE RESULT WITH THE COBAS® HIV-1 (192T) TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647006 ↗
• MalfunctionSep 19, 2025False Negative Result; False Negative Result

  THE INITIAL REPORTER ALLEGED FALSE NEGATIVE RESULTS WITH THE KIT COBAS 58/68/8800 HIV 192T IVD ON THE COBAS 6800 INSTRUMENT. THE CUSTOMER REPORTED THAT THE PATIENT'S INITIAL SCREENING TEST USING AN UNSPECIFIED COMBINATION ANTIBODY-ANTIGEN TEST RESULTED IN 61.2 S/CO. IMMUNOCHROMATOGRAPHY TESTING WAS POSITIVE FOR HIV-1 AND NEGATIVE FOR HIV-2. THE CUSTOMER REPEATED THE TEST ON THE COBAS 6800 INSTRUMENT USING THE KIT COBAS 58/68/8800 HIV 192T IVD, BUT THE RESULT WAS QUESTIONED BASED ON THE INITIAL SCREENING RESULT. THE CUSTOMER WAS UNABLE TO REPEAT THE RUN ON THE COBAS 6800 INSTRUMENT DUE TO INSUFFICIENT PATIENT SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100264 ↗
• MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS USING THE KIT COBAS 58/68/8800 HIV 192T IVD ON THE COBAS 5800 INSTRUMENT. THE ALLEGATION INVOLVED A SAMPLE TESTED WITH BOTH THE COBAS HIV-1/HIV-2 QUALITATIVE ASSAY AND THE COBAS HIV-1 QUANTITATIVE ASSAY. ON (B)(6) 2025, THE QUALITATIVE ASSAY GENERATED A REACTIVE RESULT FOR HIV-1 WITH A CYCLE THRESHOLD (CT) VALUE OF 39.1. ON (B)(6) 2025, THE QUANTITATIVE ASSAY FOR THE SAME SAMPLE RETURNED A RESULT OF 'TARGET NOT DETECTED' (TND). THE SAMPLE WAS TESTED FROM A PRIMARY TUBE CONTAINING EDTA WITH SEPARATION GEL. BETWEEN TESTS, THE SAMPLE REMAINED IN THE INSTRUMENT AND WAS NOT CENTRIFUGED. NO SEROLOGY RESULTS WERE AVAILABLE. THE LABORATORY RECEIVED SIMULTANEOUS ORDERS FOR BOTH QUALITATIVE AND QUANTITATIVE TESTS. DUE TO THE INCONCLUSIVE RESULTS, A SECOND SAMPLE WAS REQUESTED. NO HARM WAS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098320 ↗
• MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WITH THE KIT COBAS 58/68/8800 HIV 192T IVD ON THE COBAS 5800 SYSTEM. THE CUSTOMER REPORTED THAT THE SAMPLE, COLLECTED AS EDTA PLASMA USING THE BD VACUTAINER COLLECTION METHOD, WAS TESTED ON THE COBAS 5800 SYSTEM AND GENERATED A RESULT OF 'TARGET NOT DETECTED' ON (B)(6) 2025. THE SAME SAMPLE WAS TESTED TWO DAYS EARLIER ON THE QIAGEN NEUMODX PLATFORM AND GENERATED A TITER OF 1259 IU/ML. THE SAMPLE WAS TESTED FROM A SECONDARY TUBE, BUT NO INFORMATION REGARDING SAMPLE STORAGE WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098058 ↗
• MalfunctionSep 19, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE COBAS® HIV-1 (192T) RESULTS FROM THE COBAS 6800 ANALYZER FOR SIX PATIENTS. HIV VIRAL LOAD DEVIATIONS ARE OBSERVED IN 6 OUT OF 50 PATIENTS WHO ARE FOLLOWING THERAPY. WHEN TESTED, THE PATIENTS SHOWED HIGHER VIRAL LOADS, WHICH ARE DEEMED INCORRECT DUE TO ADHERENCE TO TREATMENT BY THE PATIENT AND HISTORICAL PATIENT RESULTS. THE FOLLOWING RESULTS WERE OBSERVED: SAMPLE: (B)(6). INITIAL TEST: ((B)(6)2025) 402 CP/ML. REPEAT TEST: ((B)(6)2025) TARGET NOT DETECTED. SAMPLE: (B)(6). INITIAL TEST: ((B)(6)2025) 827 CP/ML. REPEAT TEST: ((B)(6)2025) 169 CP/ML. SAMPLE: (B)(6). INITIAL TEST: ((B)(6)2025) 131 CP/ML. REPEAT TEST: ((B)(6)2025) <20 CP/ML. SAMPLE: (B)(6). INITIAL TEST: ((B)(6)2025) 563 CP/ML. REPEAT TEST: ((B)(6)2025) 82 CP/ML. SAMPLE: (B)(6). INITIAL TEST: ((B)(6)2025) 1040 CP/ML. REPEAT TEST: ((B)(6)2025) 1270 CP/ML. SAMPLE: (B)(6). INITIAL TEST: ((B)(6)2025) 8510 CP/ML. REPEAT TEST: ((B)(6)2025) 9090 CP/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097853 ↗
• MalfunctionSep 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED THE GENERATION OF MULTIPLE QUESTIONED RESULTS DURING ROUTINE TESTING WITH THE KIT COBAS 58/68/8800 HIV 192T IVD ASSAY ON THE COBAS 6800 PLATFORM. THE ALLEGATION INVOLVED TEN SAMPLES WITH INITIALLY POSITIVE RESULTS THAT SHOWED SIGNIFICANTLY DECREASED VIRAL LOADS UPON RETESTING. SPECIFIC DATA INCLUDED: SAMPLE ID (B)(6): INITIAL TITER 256 (TESTED (B)(6)2023), RETEST TITER 112 (TESTED (B)(6)2023). SAMPLE ID (B)(6): INITIAL TITER 240 (TESTED (B)(6)2023), RETEST TND (TESTED (B)(6)2023). SAMPLE ID (B)(6): INITIAL TITER 1284 (TESTED (B)(6)2023), RETEST TITER <20 (TESTED (B)(6)2023). SAMPLE ID (B)(6): INITIAL TITER 426 (TESTED (B)(6)2023), RETEST TITER 112 (TESTED (B)(6)2023). SAMPLE ID (B)(6): INITIAL TITER 846 (TESTED (B)(6)2023), RETEST TITER 260 (TESTED (B)(6)2023). SAMPLE ID (B)(6): INITIAL TITER 397 (TESTED (B)(6)2023), RETEST TITER 241 (TESTED (B)(6)2023). SAMPLE ID (B)(6): INITIAL TITER 430 (TESTED (B)(6)2023), RETEST TITER 31.6 (TESTED (B)(6)2023). SAMPLE ID (B)(6): INITIAL TITER 500 (TESTED (B)(6)2023), RETEST TITER 174 (TESTED (B)(6)2023). SAMPLE ID (B)(6): INITIAL TITER 518 (TESTED (B)(6)2023), RETEST TITER 238 (TESTED (B)(6)2023). SAMPLE ID (B)(6):

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089373 ↗
• MalfunctionSep 18, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED RESULT DISCREPANCIES IN VIRAL LOAD FOR PATIENT SAMPLES TESTED USING THE KIT COBAS 58/68/8800 HIV 192T IVD ON THE COBAS 6800 ANALYZER. THE CUSTOMER REPORTED NON-REPRODUCIBLE RESULTS FOR THE SAME PATIENT ACROSS DIFFERENT SAMPLE COLLECTIONS. FOR SAMPLE ID (B)(6) (FIRST COLLECTION ON (B)(6) 2023), THE FOLLOWING RESULTS WERE REPORTED: BATCH 234 YIELDED 273 CP/ML, BATCH 252 YIELDED A NEGATIVE RESULT, BATCH 262 YIELDED 112 CP/ML, AND BATCH 262 (REPEATED) YIELDED 88 CP/ML. FOR SAMPLE ID (B)(6) (SECOND COLLECTION ON (B)(6) 2023), THE FOLLOWING RESULTS WERE REPORTED: BATCH 254 YIELDED 135 CP/ML, BATCH 262 YIELDED A NEGATIVE RESULT, AND BATCH 262 (REPEATED) YIELDED 115 CP/ML. THE CUSTOMER USED PLASMA SAMPLES STORED AT -20°C AND VORTEXED FOR 20 SECONDS AFTER THAWING. THE RESULTS WERE NOT REPRODUCIBLE ACROSS DIFFERENT REAGENT LOTS AND TESTING BATCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088931 ↗
• MalfunctionSep 18, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF DISCREPANT RESULTS WITH THE COBAS® HIV-1 (192T) WITH ONE PATIENT SAMPLE TESTED ON A COBAS 5800 ANALYZER. IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF TARGET NOT DETECTED (TND) RESULTS AND REPORTED GOOD ADHERENCE TO ANTIRETROVIRAL THERAPY (ARV). ON (B)(6) 2025: THE SAMPLE WAS TESTED AT ANOTHER LAB ON THE COBAS 6800 ANALYZER AND THE RESULT WAS <20 CP/ML. ON (B)(6) 2025: THE SAMPLE WAS TESTED ON THE COBAS 5800 ANALYZER USING A DIFFERENT SAMPLE AND THE RESULT WAS 2900 CP/ML. THE SAMPLE WAS ALSO SENT FOR GENOTYPING TEST; NO RESULTS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086621 ↗
• MalfunctionSep 17, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED AN INCREASE IN FALSE POSITIVE RESULTS FOR PATIENT SAMPLES TESTED USING THE KIT COBAS 58/68/8800 HIV 192T IVD ON THE COBAS 6800 ANALYZER. THE ALLEGATION WAS BASED ON REPEAT TESTING OF PATIENT SAMPLES, WHICH CONFIRMED THE PRESENCE OF FALSE POSITIVE RESULTS. NO ADDITIONAL DETAILS REGARDING SPECIFIC TEST RESULTS OR DATES WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075927 ↗
• MalfunctionSep 17, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED A FALSE NEGATIVE RESULT WITH THE KIT COBAS 58/68/8800 HIV 192T IVD ASSAY WHEN TESTED ON THE COBAS 5800 ANALYZER. THE ALLEGATION INVOLVES A PREGNANT PATIENT WHO WAS DIAGNOSED AS HIV ANTIBODY POSITIVE THROUGH SEROLOGY TESTING USING THE GEENIUS HIV ½ SUPPLEMENTAL ASSAY AND HIV AB/AG SCREENING. HOWEVER, THE HIV-1/HIV-2 QUANT ASSAY ON THE COBAS 5800 ANALYZER PRODUCED A NEGATIVE RESULT FOR VIRAL LOAD. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS NOT TREATED WITH ANY HIV-RELATED MEDICATIONS. NO HARM WAS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070665 ↗
• MalfunctionSep 16, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WERE GENERATED DURING VERIFICATION ANALYSIS OF THE KIT COBAS 58/68/8800 HIV 192T IVD ON THE COBAS 5800 ANALYZER WHEN COMPARED TO RESULTS PREVIOUSLY OBTAINED ON THE COBAS 4800 ANALYZER. THE CUSTOMER PERFORMED TESTING ON 21 PATIENT PLASMA SAMPLES. THE SAMPLES WERE COLLECTED IN GEL TUBES, PLASMA WAS SEPARATED, AND THE SAMPLES WERE STORED AT -25°C AND -20°C. THE SAMPLES WERE FROZEN ONCE PRIOR TO MEASUREMENT ON THE COBAS 4800 ANALYZER IN (B)(6) 2022 AND A SECOND TIME PRIOR TO MEASUREMENT ON THE COBAS 5800 ANALYZER IN (B)(6) 2022. TESTING WAS CONDUCTED THREE TIMES AS PART OF THE VERIFICATION PROCESS. TWO OF THE 21 SAMPLE RESULTS FOR HIV WERE QUESTIONED. FOR SAMPLE ID (B)(6), TESTING ON THE COBAS 5800 ANALYZER ON (B)(6) 2022 GENERATED AN HIV TITER OF 20 CP/ML. RETESTING ON (B)(6) 2022 GENERATED AN HIV TITER OF 52.2 CP/ML. THE HIV TITER PREVIOUSLY GENERATED ON THE COBAS 4800 ANALYZER WAS 72.5 CP/ML. FOR SAMPLE ID (B)(6), TESTING ON THE COBAS 5800 ANALYZER ON (B)(6) 2022 GENERATED AN HIV TITER OF 7031.3 CP/ML. RETESTING ON (B)(6) 2022 GENERATED AN HIV TITER OF 10181.7 CP/ML. THE HIV TITER PREVIOUSLY GENERATED ON THE COBAS 4800 ANALYZER WAS 206

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23067274 ↗
• MalfunctionSep 16, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS GENERATED FOR A SAMPLE TESTED WITH THE KIT COBAS 58/68/8800 HIV 192T IVD ON THE COBAS 6800 ANALYZER, COMPARING RESULTS FROM EDTA PLASMA LIQUID SAMPLES VERSUS PLASMA SEPARATION CARD (PSC) SAMPLES. THE CUSTOMER PROVIDED DATA FOR ANALYSIS, WHICH INCLUDED THE FOLLOWING RESULTS: FOR SAMPLE ID: (B)(6), THE EDTA PLASMA LIQUID SAMPLE GENERATED A TITER OF 881,489.1849 CP/ML. FOR SAMPLE ID: (B)(6), THE PSC RUNS GENERATED TITERS OF 233,649.2329 CP/ML AND 325,590.1356 CP/ML. FOR SAMPLE ID: (B)(6), THE PSC RUNS GENERATED A TITER OF 77,769.2478 CP/ML AND AN INVALID RESULT WITH ERROR CODES. MULTIPLE QS INVALIDS WERE IDENTIFIED IN THE PSC RUNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065072 ↗
• MalfunctionSep 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH MULTIPLE PATIENT SAMPLES USING THE COBAS® HIV-1 (192T) ASSAY TESTED ON THE COBAS 6800 INSTRUMENT. THE CUSTOMER OBSERVED AN INCREASE IN HIV-1 SAMPLE TITERS RANGING FROM 20-200 COPIES/ML. DATA PROVIDED BY THE CUSTOMER INCLUDED MULTIPLE SAMPLES GENERATING RESULTS OF "TITER MIN" WITH A VALUE OF 20 COPIES/ML. SPECIFIC EXAMPLES INCLUDE: ON (B)(6) 2025, 1 SAMPLE WITH "TITER MIN" 20 COPIES/ML. ON (B)(6) 2025, 3 SAMPLES WITH "TITER MIN" 20 COPIES/ML. ON (B)(6) 2025, 2 SAMPLES WITH "TITER MIN" 20 COPIES/ML. ON (B)(6) 2025, 3 SAMPLES WITH "TITER MIN" 20 COPIES/ML. ADDITIONAL SAMPLES WITHIN THE DATA SET ALSO GENERATED RESULTS OF "TITER MIN" WITH TITERS RANGING FROM 20-200 COPIES/ML AS REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058200 ↗
• MalfunctionSep 5, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF DISCREPANT COBAS® HIV-1 (192T) RESULTS FROM THE COBAS 6800 ANALYZER FOR A SINGLE PATIENT. ON (B)(6) 2025, THE INITIAL SAMPLE GENERATED THE FOLLOWING RESULTS: HIV TITER4.20E+2CP/ML SAMPLE DILUTED FLAG. HIV-1/2-AK+P24-AG NEGATIVE. ON (B)(6) 2025, THE SAMPLE WAS REPEATED AND GENERATED THE FOLLOWING RESULTS: HIV TITER 7.17E+001 CP/ML. HIV-1/2-AK+P24-AG NEGATIVE. ON (B)(6) 2025: AN INDEPENDENT NEW DRAW IN ANOTHER LABORATORY WAS PERFORMED AND WITH THE HOLOGIC TEST GENERATED THE FOLLOWING RESULTS: HIV-1/2 SCREENING (ECLIA): NEGATIVE. HIV-RNA (TMA): NOT DETECTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22982331 ↗
• MalfunctionAug 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF AN INCREASED PROPORTION OF SAMPLES WITH RESULTS >50 CP/ML WHEN USING THE COBAS® HIV-1 (192T) ON A COBAS 5800 ANALYZER. NO SPECIFIC SAMPLES WERE ALLEGED, BUT RATHER THE CUSTOMER ALLEGED THAT THEY HAD OBSERVED AN INCREASED PROPORTION OF SAMPLES WITH RESULTS >50 CP/ML WITH THE CURRENT ASSAY WHEN COMPARED TO THE COBAS AMPLIPREP/COBAS TAQMAN HIV-1 QUANTITATIVE TEST, V2.0, AND OTHER METHODS. IT WAS INDICATED THAT SOME OF THE SAMPLES ARE EXPECTED TO BE LOWER THAN 50 CP/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22925824 ↗
• MalfunctionAug 28, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF DISCREPANT COBAS® HIV-1 RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8800 ANALYZER. ON (B)(6) 2024, THE INITIAL RESULT WAS 82,000 CP/ML. THIS RESULT WAS UNEXPECTED AS THE PATIENT IS USUALLY AROUND 134 CP/ML. ON (B)(6) 2024, THE SAME SAMPLE TUBE WAS REPEATED AND THE RESULT WAS 13,600 CP/ML. DATE UNKNOWN, A NEW SAMPLE WAS OBTAINED FROM THE PATIENT AND THE RESULT WAS ACCORDING TO THE EXPECTED VALUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914127 ↗
• MalfunctionAug 20, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF DISCREPANT COBAS® HIV-1 (192T) RESULTS FROM THE COBAS 5800 ANALYZER FOR A SINGLE PATIENT. ON (B)(6) 2025, THE INITIAL SAMPLE WAS GENERATED A POSITIVE HIV RESULT 4 TIMES ON THE COBAS 5800 WITH THE FOLLOWING RESULTS: -TITER 21 CP/ML (LOGTITER 1.33) -< TITER MIN. -TITER 29 CP/ML (LOGTITER 1.46). -TITER 39 CP/ML (LOGTITER 1.56)". SEROLOGY FOR THE INITIAL SAMPLE WAS NEGATIVE. THE SAMPLE WAS RECOLLECTED AND GENERATED "TARGET NOT DETECTED" RESULTS FOR HIV WITH BOTH THE COBAS® HIV-1 (192T) ON THE C6800 TEST AND THE SEROLOGY TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850682 ↗