Atellica™ IM aHCV 10995456Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00630414597867), received between Jun 24, 2020 and Aug 27, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (22 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026False Negative Result

  The customer reports observation of a nonreactive (negative) Atellica IM Hepatitis C (aHCV) result which was discordant relative to patient history and alternate-method testing.A nonreactive (negative) Atellica IM aHCV result was obtained for a 43-year-old male patient with chronic HCV. The patient, who undergoes regular health checkups and is in stable health with no reported issues, indicated that a previous test at another lab had been reactive (positive). The sample was re-tested, and the initial nonreactive Atellica IM aHCV result was reproduced, while a Roche Cobas HCV test produced a strongly reactive (positive) result. Additionally, the same sample was tested the next day using an Abbott Alinity platform, and a reactive result was obtained.The Atellica IM aHCV result was identified as a false negative result.There are no allegations of any adverse patient consequences in association with the observed result discordance.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50473257 ↗
• MalfunctionFeb 11, 2026False Negative Result

  THE CUSTOMER COMPLAINS ABOUT DISCORDANT NON-REACTIVE (NEGATIVE) ATELLICA IM HEPATITIS C (AHCV) RESULTS ON ONE PATIENT COMPARED TO POSITIVE RESULTS WITH ALTERNATE TEST METHODS. THE PATIENT WAS FIRST TESTED AT A NON-CUSTOMER SITE AND RESULTED POSITIVE. THE SAMPLE WAS SENT TO THE CUSTOMER SITE AND TESTED WITH ATELLICA IM HEPATITIS C (AHCV) FOR CONFIRMATION BUT RESULTED NEGATIVE (NON-REACTIVE). THE NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. SUBSEQUENTLY, ANOTHER SAMPLE WAS DRAWN FROM THE SAME PATIENT AND TESTED AT THE INITIAL NON-CUSTOMER SITE AND AGAIN RESULTED POSITIVE. THE SAMPLE WAS SENT TO THE CUSTOMER SITE AND TESTED WITH ATELLICA IM HEPATITIS C (AHCV) FOR CONFIRMATION BUT AGAIN RESULTED NEGATIVE (NON-REACTIVE). ANOTHER SAMPLE WAS DRAWN FROM THE PATIENT AND SENT FOR HCV PCR TESTING, WHICH RESULTED POSITIVE. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313273 ↗
• MalfunctionFeb 11, 2026False Negative Result

  THE CUSTOMER COMPLAINS ABOUT DISCORDANT NON-REACTIVE (NEGATIVE) ATELLICA IM HEPATITIS C (AHCV) RESULTS ON ONE PATIENT COMPARED TO POSITIVE RESULTS WITH ALTERNATE TEST METHODS. THE PATIENT WAS FIRST TESTED AT A NON-CUSTOMER SITE AND RESULTED POSITIVE. THE SAMPLE WAS SENT TO THE CUSTOMER SITE AND TESTED WITH ATELLICA IM HEPATITIS C (AHCV) FOR CONFIRMATION BUT RESULTED NEGATIVE (NON-REACTIVE). THE NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. SUBSEQUENTLY, ANOTHER SAMPLE WAS DRAWN FROM THE SAME PATIENT AND TESTED AT THE INITIAL NON-CUSTOMER SITE AND AGAIN RESULTED POSITIVE. THE SAMPLE WAS SENT TO THE CUSTOMER SITE AND TESTED WITH ATELLICA IM HEPATITIS C (AHCV) FOR CONFIRMATION BUT AGAIN RESULTED NEGATIVE (NON-REACTIVE). ANOTHER SAMPLE WAS DRAWN FROM THE PATIENT AND SENT FOR HCV PCR TESTING, WHICH RESULTED POSITIVE. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313265 ↗
• MalfunctionJan 6, 2026False Negative Result

  THE CUSTOMER REPORTED THAT THEY OBTAINED FALSE NEGATIVE ATELLICA IM HEPATITIS C (AHCV, 482) RESULTS ON TWO PATIENT SAMPLES VS ALTERNATE METHOD. THE FALSE NEGATIVE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE METHOD, AND POSITIVE RESULTS WERE OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973341 ↗
• MalfunctionSep 2, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTS AN OBSERVATION OF NON-REACTIVE (NEGATIVE) HEPATITIS C (AHCV) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1600 ANALYZER, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING ON TWO ALTERNATE METHODS WHEN USING LOT 480. AN INITIAL REACTIVE (POSITIVE) RESULT WAS OBTAINED ON ALTERNATE METHOD 1 WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RETESTED ON AN ATELLICA IM 1600 ANALYZER AND OBTAINED A NON-REACTIVE (NEGATIVE) RESULT AND ALSO RETESTED ON AN ALTERNATE METHOD 2 AND OBTAINED A REACTIVE (POSITIVE) RESULT, WHICH WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936148 ↗
• MalfunctionJul 15, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A FALSE NEGATIVE PATIENT RESULT WHEN USING ATELLICA IM HEPATITIS C (AHCV), LOT 464. THE CUSTOMER SERVES AS A REGIONAL REFERENCE LAB, AND RECEIVED A SAMPLE WHICH WAS INITIALLY POSITIVE FOR HCV FOR CONFIRMATORY TESTING. WHEN TESTED USING ATELLICA IM AHCV, A NONREACTIVE RESULT WAS OBTAINED. THIS RESULT WAS NOT REPORTED. ADDITIONAL TESTING USING AN ALTERNATE ASSAY METHOD AND WESTERN BLOT PRODUCED POSITIVE RESULTS. FURTHER TESTING WAS NOT POSSIBLE DUE TO INSUFFICIENT SAMPLE VOLUME. THE SAMPLE WAS CONFIRMED TO BE HCV-REACTIVE. THE NONREACTIVE ATELLICA IM AHCV RESULT WAS IDENTIFIED AS DISCORDANT AND ERRONEOUS. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR ANY OTHER ADVERSE CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740828 ↗
• MalfunctionSep 8, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A FALSE NEGATIVE RESULT FOR A PATIENT SAMPLE WHEN RUNNING ATELLICA IM HEPATITIS C (AHCV), LOT 440. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S).THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AND A SIMILAR RESULT WAS OBTAINED. THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE METHOD AND A HIGHER RESULT WAS OBTAINED. THE ALTERNATE METHOD RESULT WAS AGREED WITH THE CONFIRMATORY METHOD (RIBA). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, HCV RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17709835 ↗
• MalfunctionAug 11, 2023False Negative Result; False Negative Result

  NONREACTIVE (NEGATIVE) HEPATITIS C (AHCV) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1600 ANALYZER WHICH WERE CONSIDERED DISCORDANT WITH THE REACTIVE (POSITIVE) RESULTS FROM AN ALTERNATE METHOD. THE DISCORDANT NONREACTIVE (NEGATIVE) RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NONREACTIVE AHCV RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17511930 ↗
• MalfunctionAug 10, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF REPRODUCIBLE NONREACTIVE (NEGATIVE) ATELLICA IM HEPATITIS C (AHCV) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO PATIENT HISTORY AND ALTERNATE-METHOD TESTING. THE PATIENT IN QUESTION PRODUCED A SERIES OF THREE NONREACTIVE AHCV RESULTS IN REPEAT TESTING. THE PATIENT HAD A HISTORY OF POSITIVE HCV RESULTS BY AN ALTERNATE TESTING METHOD (GOING BACK TO 2016); THE NEGATIVE AHCV RESULTS WERE CONSIDERED INCORRECT AND NOT REPORTED. THE SAMPLE WAS ALSO TESTED FOLLOWING TREATMENT WITH INHIBITORS OF HETEROPHILIC ANTIBODIES (HETEROPHILIC BLOCKING TUBE, HBT) FOR INVESTIGATION/TROUBLESHOOTING, AND PRODUCED A NEGATIVE RESULT. USING HETEROPHILIC-BLOCKING TUBE). THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17503030 ↗
• MalfunctionMay 11, 2023False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED REPRODUCIBLE, NON REACTIVE RESULTS ON ONE SERUM PATIENT SAMPLE WITH ATELLICA IM HEPATITIS C (AHCV), LOT 440. THE RESULTS WERE CONSIDERED DISCORDANT COMPARED TO A LOW POSITIVE RESULT ON AN ALTERNATE METHOD. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATELLICA IM AHCV RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916439 ↗
• MalfunctionOct 3, 2022False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A DISCORDANT HEPATITIS C (AHCV) NEGATIVE PATIENT RESULT FOR A PATIENT USING THE ATELLICA IM 1600 ANALYZER. THE RESULT WAS POSITIVE WHEN TESTED BY AN ALTERNATE METHOD. THE ATELLICA IM AHCV RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NEGATIVE AHCV RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15528002 ↗
• MalfunctionAug 26, 2022False Negative Result; False Negative Result

  THE CUSTOMER OBTAINED REPEAT FALSE NEGATIVE (NONREACTIVE) ATELLICA IM HEPATITIS C (AHCV) RESULTS ON ONE PATIENT. THE INITIAL NEGATIVE (NONREACTIVE) RESULT (B)(6) 2022) WAS REPORTED AND WAS QUESTIONED, SINCE THE PATIENT HAD AN HISTORICAL POSITIVE (REACTIVE) AHCV RESULT FROM (B)(6) 2021. THE SAMPLE FROM (B)(6) 2022 WAS SENT TO A REFERENCE LABORATORY FOR CONFIRMATION TESTING; THE RESULT WAS REACTIVE FOR AHCV, BUT AN RNA PCR RESULT WAS NEGATIVE. THE CUSTOMER FROZE THE SAMPLE AND IN (B)(6) 2022, PERFORMED ADDITIONAL TESTING. A NONREACTIVE RESULT WAS OBTAINED WITH ATELLICA IM AHCV, BUT A REACTIVE RESULT WAS OBTAINED AGAIN AT THE REFERENCE LABORATORY. IT IS UNKNOWN WHAT WAS REPORTED AS THE FINAL RESULT FOR THIS PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NONREACTIVE AHCV RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303602 ↗
• MalfunctionAug 26, 2022False Negative Result; False Negative Result

  THE CUSTOMER OBTAINED REPEAT FALSE NEGATIVE (NONREACTIVE) ATELLICA IM HEPATITIS C (AHCV) RESULTS ON ONE PATIENT. THE INITIAL NEGATIVE (NONREACTIVE) RESULT (B)(6) 2022) WAS REPORTED AND WAS QUESTIONED, SINCE THE PATIENT HAD AN HISTORICAL POSITIVE (REACTIVE) AHCV RESULT FROM (B)(6) 2021. THE SAMPLE FROM (B)(6) 2022 WAS SENT TO A REFERENCE LABORATORY FOR CONFIRMATION TESTING; THE RESULT WAS REACTIVE FOR AHCV, BUT AN RNA PCR RESULT WAS NEGATIVE. THE CUSTOMER FROZE THE SAMPLE AND IN (B)(6) 2022, PERFORMED ADDITIONAL TESTING. A NONREACTIVE RESULT WAS OBTAINED WITH ATELLICA IM AHCV, BUT A REACTIVE RESULT WAS OBTAINED AGAIN AT THE REFERENCE LABORATORY. IT IS UNKNOWN WHAT WAS REPORTED AS THE FINAL RESULT FOR THIS PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NONREACTIVE AHCV RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303566 ↗
• MalfunctionJul 25, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED TWO DISCORDANT HEPATITIS C (AHCV) NEGATIVE PATIENT RESULTS FOR TWO PATIENTS USING THE ATELLICA IM 1600 ANALYZER. THE RESULTS WERE EQUIVOCAL WHEN TESTED BY AN ALTERNATE METHOD (BLOT). THE ATELLICA IM AHCV RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NEGATIVE AHCV RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094603 ↗
• MalfunctionMar 2, 2022False Negative Result; False Negative Result

  CUSTOMER OBSERVED (B)(6) ATELLICA IM HEPATITIS C (AHCV) RESULTS FROM TWO SAMPLES THAT WERE CONSIDERED DISCORDANT ON COMPARISON WITH THE REPEAT RESULTS FROM TWO DIFFERENT ALTERNATE PLATFORMS. THERE WERE NO REPORTS THAT TREATMENT WAS ALTERED OR POSTPONED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653407 ↗
• MalfunctionMar 2, 2022False Negative Result; False Negative Result

  CUSTOMER OBSERVED REPRODUCIBLE NONREACTIVE ATELLICA IM HEPATITIS C (AHCV) RESULTS FROM TWO SAMPLES THAT WERE CONSIDERED DISCORDANT ON COMPARISON WITH THE REPEAT RESULTS FROM TWO DIFFERENT ALTERNATE PLATFORMS. THERE WERE NO REPORTS THAT TREATMENT WAS ALTERED OR POSTPONED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NONREACTIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653400 ↗
• MalfunctionMar 2, 2022False Negative Result; False Negative Result

  CUSTOMER OBSERVED REPRODUCIBLE NONREACTIVE ATELLICA IM HEPATITIS C (AHCV) RESULTS FROM TWO SAMPLES THAT WERE CONSIDERED DISCORDANT ON COMPARISON WITH THE REPEAT RESULTS FROM TWO DIFFERENT ALTERNATE PLATFORMS. THERE WERE NO REPORTS THAT TREATMENT WAS ALTERED OR POSTPONED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NONREACTIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653398 ↗
• MalfunctionNov 25, 2020False Negative Result; False Negative Result

  SIEMENS WAS INFORMED BY THE CUSTOMER OF A FALSE NEGATIVE ATELLICA IM (B)(6) RESULT OBTAINED ON A NEW SAMPLE FROM THE SAME PATIENT INITIALLY REPORTED (REFERENCE MDRS 1219913-2020-00155, 1219913-2020-00156, 1219913-2020-00157 AND 1219913-2020-00158). THE NEGATIVE (B)(6) RESULT IS CONSIDERED DISCORDANT BECAUSE IT IS FROM A PATIENT WHO WAS KNOWN (B)(6) POSITIVE SINCE 2007. THE INITIAL PATIENT SAMPLE WAS NOT AVAILABLE FOR TESTING BY SIEMENS AND THE INVESTIGATION WAS CONCLUDED ON (B)(6) 2020. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY NEGATIVE ATELLICA IM (B)(6) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10907271 ↗
• MalfunctionJun 24, 2020False Negative Result; False Negative Result

  FALSE NEGATIVE (B)(6) RESULTS WERE OBTAINED ON SAMPLES FROM THE SAME PATIENT AND QUESTIONED BY THE PHYSICIAN(S). THE NEGATIVE (B)(6) RESULTS ARE CONSIDERED DISCORDANT COMPARED TO A KNOWN (B)(6) POSITIVE PATIENT SINCE 2007. THE PATIENT HAD POSITIVE (B)(6) RESULTS ON (B)(6) 2019, HOWEVER ADDITIONAL (B)(6) PATIENT TESTING PERFORMED IN (B)(6) 2020 WITH A DIFFERENT (B)(6) REAGENT LOT ON THE ORIGINAL ATELLICA SYSTEM (#1) AND A SECOND ATELLICA SYSTEM (#2) WERE NEGATIVE. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT(S), FALSELY NEGATIVE ATELLICA IM (B)(6) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10192337 ↗
• MalfunctionJun 24, 2020False Negative Result; False Negative Result

  FALSE NEGATIVE (B)(6) RESULTS WERE OBTAINED ON SAMPLES FROM THE SAME PATIENT AND QUESTIONED BY THE PHYSICIAN(S). THE NEGATIVE (B)(6) RESULTS ARE CONSIDERED DISCORDANT COMPARED TO A KNOWN (B)(6) POSITIVE PATIENT SINCE 2007. THE PATIENT HAD POSITIVE (B)(6) RESULTS ON (B)(6) 2019, HOWEVER ADDITIONAL (B)(6) PATIENT TESTING PERFORMED IN (B)(6) 2020 WITH A DIFFERENT (B)(6) REAGENT LOT ON THE ORIGINAL ATELLICA SYSTEM (#1) AND A SECOND ATELLICA SYSTEM (#2) WERE NEGATIVE. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT(S), FALSELY NEGATIVE ATELLICA IM (B)(6) RESULTS

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10192335 ↗
• MalfunctionJun 24, 2020False Negative Result; False Negative Result

  FALSE NEGATIVE (B)(6) RESULTS WERE OBTAINED ON SAMPLES FROM THE SAME PATIENT AND QUESTIONED BY THE PHYSICIAN(S). THE NEGATIVE (B)(6) RESULTS ARE CONSIDERED DISCORDANT COMPARED TO A KNOWN (B)(6) POSITIVE PATIENT SINCE 2007. THE PATIENT HAD POSITIVE (B)(6) RESULTS ON (B)(6) 2019, HOWEVER ADDITIONAL (B)(6) PATIENT TESTING PERFORMED IN (B)(6) 2020 WITH A DIFFERENT (B)(6) REAGENT LOT ON THE ORIGINAL ATELLICA SYSTEM (#1) AND A SECOND ATELLICA SYSTEM (#2) WERE NEGATIVE. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT(S), FALSELY NEGATIVE ATELLICA IM (B)(6) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10192334 ↗
• MalfunctionJun 24, 2020False Negative Result; False Negative Result

  FALSE NEGATIVE (B)(6) RESULTS WERE OBTAINED ON SAMPLES FROM THE SAME PATIENT AND QUESTIONED BY THE PHYSICIAN(S). THE NEGATIVE (B)(6) RESULTS ARE CONSIDERED DISCORDANT COMPARED TO A KNOWN (B)(6) POSITIVE PATIENT SINCE 2007. THE PATIENT HAD POSITIVE (B)(6) RESULTS ON (B)(6) 2019, HOWEVER ADDITIONAL (B)(6) PATIENT TESTING PERFORMED IN (B)(6) 2020 WITH A DIFFERENT (B)(6) REAGENT LOT ON THE ORIGINAL ATELLICA SYSTEM (#1) AND A SECOND ATELLICA SYSTEM (#2) WERE NEGATIVE. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT(S), FALSELY NEGATIVE ATELLICA IM (B)(6) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10192333 ↗