Atellica™ IM ThCG 10995689Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00630414600024), received between May 3, 2019 and Apr 17, 2026 — classified as 40 malfunctions.

The most frequently reported specific device problem is “High Test Results” (30 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT ON A PATIENT SAMPLE ON AN ATELLICA IM 1300 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAMPLE WAS REPEATED TWICE ON THE SAME ANALYZER, AND THE REPEAT RESULTS WERE LOWER THAN THE INITIAL RESULT. THE REPEAT RESULTS WERE CONSISTENT WITH PATIENT¿S CLINICAL HISTORY, CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED WITH THE RESULT AS <5 IU/L. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24914334 ↗
• MalfunctionMar 9, 2026Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT A DEPRESSED ATELLICA IM TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT# 365. AN ERRONEOUSLY DEPRESSED RESULT OF 895.7MIU/ML WAS INITIALLY REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE PATIENT WAS REDRAWN, THE SAMPLE WAS DILUTED (1:5), AND RETESTED ON THE SAME ATELLICA IM 1600 ANALYZER, YIELDING A RESULT OF 2331.1MIU/ML. THE PATIENT WAS DRAWN AGAIN, AND THE NEW SAMPLE PROCESSED ON THE SAME ANALYZER PRODUCED A RESULT OF 2435.6 MIU/ML. THE ELEVATED RESULTS WERE CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION AND ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543659 ↗
• MalfunctionJul 21, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF AN ELEVATED ATELLICA IM TOTAL HCG (THCG) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT# 362. AN INITIAL ELEVATED THCG RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), BUT IT IS UNKNOWN IF THE RESULT WAS QUESTIONED BY THE PHYSICIAN(S). A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND TESTED ON THE ORIGINAL ANALYZER WHICH PRODUCED A LOWER RESULT. FOR TROUBLESHOOTING PURPOSES, BOTH SAMPLES WERE RETESTED ON AN ALTERNATE ANALYZER (ATELLICA CI 1900), WHICH PRODUCED LOWER RESULTS SIMILAR TO THE RESULT OBTAINED FROM THE SECOND SAMPLE. THE LOWER RESULT WAS CONSIDERED CORRECT, AND A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN(S) BASED ON REPEAT TESTING. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554131 ↗
• MalfunctionJul 1, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED AN OBSERVATION OF DEPRESSED ATELLICA IM TOTAL HCG (THCG, LOT# 363) RESULTS ON TWO SAMPLES DRAWN FROM A PATIENT, WHICH WERE DISCORDANT RELATIVE TO ALTERNATE METHOD(S) TESTING. THE INITIAL RESULT FROM THE FIRST SAMPLE WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. TWO DAYS LATER, THE SAME SAMPLE WAS RETESTED ON TWO ATELLICA IM 1300 ANALYZERS, AND SIMILAR DEPRESSED RESULTS WERE OBTAINED, WHICH WERE CONSIDERED DISCORDANT. ADDITIONALLY, A NEW (SECOND) SAMPLE FROM THE SAME PATIENT WAS TESTED AND/OR RETESTED ON TWO ATELLICA IM 1300 ANALYZERS, AND SIMILAR DEPRESSED RESULTS WERE OBTAINED, WHICH WERE CONSIDERED DISCORDANT. THE DISCORDANT RESULTS FROM BOTH SAMPLES WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE FIRST SAMPLE WAS RESTED ON AN ATELLICA IM 1300 ANALYZER, AND THE RESULT RECOVERED GREATER THAN THE MEASURING INTERVAL, WHICH WAS REPORTED TO THE PHYSICIAN(S). SUBSEQUENTLY, THE FIRST SAMPLE WAS RETESTED MULTIPLE TIMES ON TWO ATELLICA IM 1300 ANALYZERS USING DIFFERENT DILUTION FACTORS. THE REPEAT RESULTS RECOVERED GREATER THAN THE MEASURING INTERVAL AND WERE REPORTED TO THE PHYSICIAN(S). SIMILARLY, THE NEW (SECOND) SAMPLE WAS RESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369134 ↗
• MalfunctionJul 1, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED AN OBSERVATION OF DEPRESSED ATELLICA IM TOTAL HCG (THCG, LOT# 363) RESULTS ON TWO SAMPLES DRAWN FROM A PATIENT, WHICH WERE DISCORDANT RELATIVE TO ALTERNATE METHOD(S) TESTING. THE INITIAL RESULT FROM THE FIRST SAMPLE WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. TWO DAYS LATER, THE SAME SAMPLE WAS RETESTED ON TWO ATELLICA IM 1300 ANALYZERS, AND SIMILAR DEPRESSED RESULTS WERE OBTAINED, WHICH WERE CONSIDERED DISCORDANT. ADDITIONALLY, A NEW (SECOND) SAMPLE FROM THE SAME PATIENT WAS TESTED AND/OR RETESTED ON TWO ATELLICA IM 1300 ANALYZERS, AND SIMILAR DEPRESSED RESULTS WERE OBTAINED, WHICH WERE CONSIDERED DISCORDANT. THE DISCORDANT RESULTS FROM BOTH SAMPLES WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THEN, THE FIRST SAMPLE WAS RESTED ON AN ATELLICA IM 1300 ANALYZER, AND THE RESULT RECOVERED GREATER THAN THE MEASURING INTERVAL, WHICH WAS REPORTED TO THE PHYSICIAN(S). SUBSEQUENTLY, THE FIRST SAMPLE WAS RETESTED MULTIPLE TIMES ON TWO ATELLICA IM 1300 ANALYZERS USING DIFFERENT DILUTION FACTORS. THE REPEAT RESULTS RECOVERED GREATER THAN THE MEASURING INTERVAL AND WERE REPORTED TO THE PHYSICIAN(S). SIMILARLY, THE NEW (SECOND) SAMPLE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369126 ↗
• MalfunctionMay 9, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM TOTAL HCG (THCG) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT 362. AN INITIAL ELEVATED RESULT WAS OBTAINED FOR ONE (1) PATIENT SAMPLE. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND TESTED ON THE ORIGINAL ANALYZER WHICH OBTAINED A LOWER RESULT. THE INITIAL SAMPLE WAS RETESTED ON THE ORIGINAL ANALYZER WHICH ALSO OBTAINED A SIMILAR LOWER RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT AND WAS ISSUED ON THE CORRECTED REPORT TO THE PHYSICIAN. 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 21992460 ↗
• MalfunctionJan 24, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM TOTAL HCG (THCG) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT AND ALTERNATE-METHOD TESTING WHEN USING LOT THCG 360. A 40-YEAR-OLD PATIENT PRODUCED AN ELEVATED ATELLICA IM THCG RESULT IN ADVANCE OF AN IUD (INTRAUTERINE DEVICE) INSERTION; THE PATIENT CLAIMED NOT TO BE PREGNANT. THE NEXT DAY, THE PATIENT CARRIED OUT A RAPID IMMUNOFLUORESCENCE TEST USING A CAPILLARY BLOOD SAMPLE, AND THE RESULT WAS NEGATIVE. THE ORIGINAL SAMPLE WAS RE-TESTED TWICE FOR TROUBLESHOOTING PURPOSES, AND THE RESULTS WERE STILL ELEVATED. THE PATIENT CHALLENGED THE INITIAL ELEVATED THCG RESULT, AND A NEW SAMPLE WAS COLLECTED AND MEASURED USING THE SAME INSTRUMENT. THIS SAMPLE PRODUCED A MUCH LOWER RESULT (BELOW REFERENCE CUTOFF). ADDITIONAL INVESTIGATIVE TESTING WAS PERFORMED ON THIS PATIENT¿S SAMPLES. BOTH THE FIRST AND SECOND SAMPLE WERE RE-TESTED USING A DIMENSION INSTRUMENT, AND A HIGH RESULT WAS OBTAINED FOR THE FIRST SAMPLE, AND LOW RESULT FOR THE SECOND. THE FIRST SAMPLE, WHICH HAD BEEN REPRODUCIBLY ELEVATED, WAS ALSO TESTED FOLLOWING HBT (HETEROPHILIC BLOCKING TUBE) TREATMENT. THE RESULTS FOR THIS SAMPLE WERE CONSISTENTLY ELEVATED IN DUPLICATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229554 ↗
• MalfunctionJan 23, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM TOTAL HCG (THCG) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT THCG 361. AN INITIAL ELEVATED ATELLICA IM THCG RESULT WAS OBTAINED FOR A 49-YEAR-OLD MALE PATIENT WITH TESTICULAR CANCER. THIS RESULT WAS QUESTIONED BY THE CLINICAL PATHOLOGIST, AS THE RESULT WAS HIGHER THAN EXPECTED. WITHIN TWO HOURS, THE SAME SAMPLE WAS REPEAT-TESTED TWICE ON THE SAME ANALYZER AND TWICE AS ANOTHER ATELLICA IM INSTRUMENT; THE REPEAT RESULTS WERE CONSISTENTLY LOWER (<2 IU/L). THE CONSENSUS LOWER RESULTS (FOUR OBSERVATIONS <2 IU/L) WERE ACCEPTED AS CORRECT. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE ONCOLOGIST, BUT NO ACTION IS BELIEVED TO HAVE BEEN TAKEN IN RESPONSE TO THE INITIAL RESULT. 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 21218029 ↗
• MalfunctionOct 9, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM TOTAL HCG (THCG) RESULT FOR ONE PATIENT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING THCG LOT 356. AN INITIAL ELEVATED ATELLICA IM THCG RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE SAMPLE WAS RE-TESTED THE SAME DAY, ON THE SAME ANALYZER AND ON AN ALTERNATE ATELLICA IM SYSTEM, AND BOTH REPEAT RESULTS WERE LOWER. THE INITIAL RESULT WAS IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR OTHER ADVERSE CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20406914 ↗
• MalfunctionSep 23, 2024High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ATELLICA IM TOTAL HCG (THCG) LOT 356 RESULT ON A PATIENT SAMPLE. THIS RESULT WAS REPORTED AND QUESTIONED. A NEW SAMPLE WAS DRAWN FROM THE PATIENT ON A DIFFERENT DAY AND RETESTED ON A DIFFERENT ATELLICA IM ANALYZER WITH THE SAME LOT. THE RESULT WAS LOWER AND ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20283519 ↗
• MalfunctionSep 13, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED RESULT FOR A 26-YEAR-OLD FEMALE PATIENT WITH THE ATELLICA IM THCG LOT 356. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE ANALYZER; THE SAMPLE RECOVERED LESS THAN THE ANALYTICAL MEASUREMENT RANGE VS. THE INITIAL RESULT. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S) AS A CORRECT RESULT. A CORRECTED REPORT WAS ISSUED BASED ON THE REPEAT TESTING. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211948 ↗
• MalfunctionSep 13, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM TOTAL HCG (THCG) RESULT FOR ONE PATIENT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING THCG REAGENT LOT 358. AN INITIAL ELEVATED (ABOVE THE REFERENCE RANGE FOR NON-PREGNANT FEMALES) ATELLICA IM THCG RESULT WAS OBTAINED FOR A PATIENT UNDERGOING IVF TREATMENT. THIS RESULT WAS CONSIDERED HIGH, AND THE TEST WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULT WAS <2.0 MIU/ML. THIS RESULT WAS CONFIRMED BY AN ADDITIONAL REPEAT TEST ON AN ATELLICA CI ANALYZER, WHICH ALSO PRODUCED A RESULT <2.0 MIU/ML. THE SECOND ATELLICA IM RESULT WAS REPORTED AS CORRECT. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211941 ↗
• MalfunctionAug 20, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM TOTAL HCG (THCG) RESULT WITH LOT# 356 ON A PATIENT SAMPLE WHICH WAS CONSIDERED DISCORDANT RELATIVE TO REPEAT TESTING. AN INITIAL ELEVATED RESULT WAS OBTAINED FOR A 32-YEAR-OLD FEMALE PATIENT. THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS RETESTED ON THREE DIFFERENT ATELLICA IM ANALYZERS, WHICH EACH TIME PRODUCED A SIGNIFICANTLY LOWER RESULT (BELOW ASSAY MEASURING INTERVAL). THE SAME SAMPLE WAS RETESTED ADDITIONALLY ON THE ORIGINAL ATELLICA IM ANALYZER, AND A RESULT BELOW ASSAY MEASURING INTERVAL WAS OBTAINED. THE LOWER RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005283 ↗
• MalfunctionJun 11, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS AN OBSERVATION OF DISCORDANT (ELEVATED) TOTAL HCG (THCG) RESULTS ON TWO FEMALE PATIENT SAMPLES WHEN TESTED ON AN ATELLICA IM 1600 ANALYZER VERSUS REPEAT TESTING. THE INITIAL DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE RETESTED ON THE ALTERNATE ANALYZERS AND LOWER RESULTS THAT FIT EACH PATIENT¿S MEDICAL HISTORY WERE OBTAINED AND CONSIDERED CORRECT REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511398 ↗
• MalfunctionMar 28, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM TOTAL HCG (THCG) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING THCG KIT LOT 352. ELEVATED THCG RESULTS (ABOVE ASSAY CUTOFF FOR NON-PREGNANT FEMALES) WERE OBTAINED FOR THREE FEMALE PATIENTS. REPEAT TESTING, USING THE SAME METHOD OTHER ATELLICA IM INSTRUMENTS, PRODUCED LOWER RESULTS. AS THE LOWER RESULTS WERE CONSIDERED CORRECT AS THEY WERE REPRODUCIBLE AND CONSISTENT WITH PATIENT CLINICAL PRESENTATION. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR OTHER ADVERSE CONSEQUENCES IN ASSOCIATION WITH THE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991516 ↗
• MalfunctionJan 19, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A DEPRESSED ATELLICA IM TOTAL HCG (THCG) RESULT FOR ONE PATIENT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THCG REAGENT LOT 352 WAS IN USE. AN INITIAL LOW THCG RESULT WAS OBTAINED FOR THE AFFECTED PATIENT. THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE PATIENT¿S SERUM SAMPLE WAS SENT TO ANOTHER LABORATORY FOR REPEAT TESTING USING THE SAME METHOD ON ANOTHER ATELLICA IM ANALYZER. REPEAT TESTING PRODUCED REPRODUCIBLY HIGHER RESULTS, WHICH WERE CONSIDERED BELIEVABLE. AN ADDITIONAL TEST WAS PERFORMED IN ANOTHER LABORATORY, CONFIRMING THE HIGHER RESULTS; THIS FINAL RESULT WAS ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR OTHER ADVERSE CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18543345 ↗
• MalfunctionNov 23, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A DISCORDANT ELEVATED TOTAL HCG (THCG) RESULT FOR A PATIENT SAMPLE ON ATELLICA IM 1600 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME ATELLICA IM ANALYZER AND TWO OTHER ATELLICA IM ANALYZERS AND LOWER RESULTS WERE OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, TOTAL HCG (THCG) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18197953 ↗
• MalfunctionOct 9, 2023Low Test Results; Low Test Results

  A FALSELY DEPRESSED TOTAL HCG (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1600 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS THEN REPEATED ON THE INITIAL ATELLICA IM 1600 ANALYZER AFTER RE-CENTRIFUGATION. THE REPEAT RESULT WAS HIGHER THAN THE ERRONEOUS RESULT. THE HIGHER RESULT WAS CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED TOTAL HCG (THCG) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17899027 ↗
• MalfunctionSep 29, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED AN ELEVATED ATELLICA IM ((B)(6) TOTAL HCG (THCG) LOT 348 RESULT THAT WAS CONSIDERED DISCORDANT COMPARED TO REPEAT TESTING ON A DIFFERENT ATELLICA IM. THE SAMPLE IS FROM A 25 YEAR OLD FEMALE. THE QUALITY CONTROL WAS IN RANGE AT THE TIME OF TESTING. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE PATIENT IS NOT PREGNANT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TOTAL HCG (THCG) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17841777 ↗
• MalfunctionSep 28, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A DISCORDANT ELEVATED RESULT FOR A 35-YEAR-OLD FEMALE PATIENT WHEN RUNNING TOTAL HCG (THCG) ON THE ATELLICA IM 1600 ANALYZER. AN INITIAL LOW RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO DID NOT QUESTION THE RESULT. DURING ROUTINE EVALUATION, THE SAMPLE WAS REPEATED ON A DIFFERENT ATELLICA IM ANALYZER AND A HIGHER RESULT WAS OBTAINED. THE SAMPLE WAS TESTED FOR TROUBLESHOOTING TWO ADDITIONAL TIMES ON THE BOTH ATELLICA IM ANALYZERS, AND THE RESULTS WERE HIGHER THAN THE TWO OTHER RESULTS. A NEW SAMPLE WAS TAKEN FROM THE PATIENT AND THE RESULTS WERE LOW AND COMPARABLE TO THE INITIAL RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, TOTAL HCG (THCG) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17833861 ↗
• MalfunctionSep 13, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED DISCORDANCE BETWEEN INITIAL AND RETEST RESULTS WITH ATELLICA IM TOTAL HCG (THCG) ON ONE PATIENT SAMPLE. THE INITIAL RESULT WAS ELEVATED AND HAD BEEN REPORTED TO THE PHYSICIAN BUT WAS NOT QUESTIONED. THE RETEST RESULT, OBTAINED ON A DIFFERENT INSTRUMENT, WAS LOWER. A CORRECTED REPORT WAS ISSUED WITH THE LOWER RESULT. THERE ARE NO ALLEGATIONS OF DELAY, PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741808 ↗
• MalfunctionSep 11, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM TOTAL HCG (THCG) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. AN INITIAL THCG RESULT ABOVE THE REFERENCE RANGE FOR NON-PREGNANT FEMALES WAS OBTAINED FOR A 34-YEAR-OLD FEMALE PATIENT; THIS INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RE-TESTED USING ANOTHER ATELLICA IM ANALYZER, AND A LOWER RESULT WAS PRODUCED. MULTIPLE ADDITIONAL TESTS RUN ON BOTH INSTRUMENTS PRODUCED A SERIES OF SIMILAR LOWER RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17721827 ↗
• MalfunctionMay 11, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED A TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) LOW RESULT ON A FEMALE PATIENT, ON ATELLICA IM MODULE. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). AFTER FAILING CONTROLS IN THIS ATELLICA IM MODULE, AN IMPACT ANALYSIS WAS PERFORMED, WITH REPETITION OF THE SAMPLE ON OTHER ATELLICA IM MODULES. THE REPEAT RESULTS WERE ELEVATED COMPARED TO THE INITIAL RESULT. THE SAME SAMPLE WAS AGAIN REPEATED ON THE INITIAL ATELLICA IM MODULE IN TRIPLICATE, AND THE RESULTS WERE COMPARABLE TO THE ELEVATED RESULTS. A NEW SAMPLE FROM THE SAME PATIENT WAS MEASURED ON TWO ATELLICA IM MODULES AND THE RESULTS WERE LOW AND SIMILAR TO THE INITIAL RESULT. THIS SAMPLE WAS ALSO REPEATED ON THE INITIAL ATELLICA IM MODULE AND THE RESULT REMAINED LOW. THE LOWER RESULTS WERE CONSIDERED AS CORRECT BY THE PHYSICIAN(S). THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS IN DIAGNOSIS IN ASSOCIATION WITH THE DISCORDANT ATELLICA IM ELEVATED THCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912255 ↗
• MalfunctionMay 11, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED A TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) LOW RESULT ON A FEMALE PATIENT, ON ATELLICA IM MODULE. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). AFTER FAILING CONTROLS IN THIS ATELLICA IM MODULE, AN IMPACT ANALYSIS WAS PERFORMED, WITH REPETITION OF THE SAMPLE ON OTHER ATELLICA IM MODULES. THE REPEAT RESULTS WERE ELEVATED COMPARED TO THE INITIAL RESULT. THE SAME SAMPLE WAS AGAIN REPEATED ON THE INITIAL ATELLICA IM MODULE IN TRIPLICATE, AND THE RESULTS WERE COMPARABLE TO THE ELEVATED RESULTS. A NEW SAMPLE FROM THE SAME PATIENT WAS MEASURED ON TWO ATELLICA IM MODULES AND THE RESULTS WERE LOW AND SIMILAR TO THE INITIAL RESULT. THIS SAMPLE WAS ALSO REPEATED ON THE INITIAL ATELLICA IM MODULE AND THE RESULT REMAINED LOW. THE LOWER RESULTS WERE CONSIDERED AS CORRECT BY THE PHYSICIAN(S). THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS IN DIAGNOSIS IN ASSOCIATION WITH THE DISCORDANT ATELLICA IM ELEVATED THCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912254 ↗
• MalfunctionMay 11, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED A TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) LOW RESULT ON A FEMALE PATIENT, ON ATELLICA IM MODULE. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). AFTER FAILING CONTROLS IN THIS ATELLICA IM MODULE, AN IMPACT ANALYSIS WAS PERFORMED, WITH REPETITION OF THE SAMPLE ON OTHER ATELLICA IM MODULES. THE REPEAT RESULTS WERE ELEVATED COMPARED TO THE INITIAL RESULT. THE SAME SAMPLE WAS AGAIN REPEATED ON THE INITIAL ATELLICA IM MODULE IN TRIPLICATE, AND THE RESULTS WERE COMPARABLE TO THE ELEVATED RESULTS. A NEW SAMPLE FROM THE SAME PATIENT WAS MEASURED ON TWO ATELLICA IM MODULES AND THE RESULTS WERE LOW AND SIMILAR TO THE INITIAL RESULT. THIS SAMPLE WAS ALSO REPEATED ON THE INITIAL ATELLICA IM MODULE AND THE RESULT REMAINED LOW. THE LOWER RESULTS WERE CONSIDERED AS CORRECT BY THE PHYSICIAN(S). THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS IN DIAGNOSIS IN ASSOCIATION WITH THE DISCORDANT ATELLICA IM ELEVATED THCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912251 ↗