Atellica™ IM ThCG 10995690Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00630414600031), received between Jul 19, 2019 and Feb 19, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “High Test Results” (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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026High Test Results

  THE CUSTOMER REPORTED AN OBSERVATION OF AN ELEVATED ATELLICA IM TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG, LOT # 365) PATIENT RESULT FOR A SAMPLE, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS RETESTED ON THE ORIGINAL ATELLICA IM 1300 ANALYZER. THE RETESTED RESULT WAS LOWER THAN THE INITIAL RESULT AND WAS IN LINE WITH THE CUSTOMERS¿ EXPECTATIONS. A CORRECTED REPORT WAS ISSUED BY REPORTING THE RETESTED RESULT 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 24385781 ↗
• MalfunctionDec 3, 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 THCG LOT 364. THE CUSTOMER TESTED THE SAMPLE OF A 17-YEAR-OLD FEMALE PATIENT BOTH NEAT AND DILUTED 200-FOLD. THE RESULT FOR THE DILUTED SAMPLE WAS ELEVATED, WHILE THE UNDILUTED RESULT WAS BELOW ASSAY MEASURING RANGE. THE ELEVATED RESULT WAS REPORTED, AND LATER IDENTIFIED AS FALSELY ELEVATED. WHEN THE SAME SAMPLE WAS REPEAT TESTED ON THE SAME INSTRUMENT, THE NEAT (UNDILUTED) RESULT WAS THE SAME (BELOW RANGE), AND THE DILUTION PRODUCED AN OVERDILUTION ERROR (OVERDILUTED; BELOW LINEARITY). A SECOND SAMPLE WAS TESTED TWICE ON A DIFFERENT ATELLICA IM ANALYZER, AND IT REPRODUCED THE LOW RESULTS SEEN IN THE RE-TEST OF THE FIRST SAMPLE. WHEN BOTH SAMPLES WERE SENT TO AN EXTERNAL LABORATORY FOR TESTING, RESULTS FROM A ROCHE COBAS SYSTEM WERE NON-DETECTABLE FOR HCG. ADDITIONALLY, AN OVARIAN ULTRASOUND WAS PERFORMED SHOWING NO OVARIAN PATHOLOGY. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE. NO ISSUES WERE IDENTIFIED WITH QUALITY CONTROL (QC) OR ANY OTHER SAMPLE RESUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704621 ↗
• MalfunctionSep 11, 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 THCG LOT: 362. A DISCORDANT ELEVATED THCG RESULT WAS OBSERVED AMONG A SERIES OF TESTS FOR ONE PATIENT. THE SAMPLE WAS TESTED MULTIPLE TIMES, ON TWO INSTRUMENTS, DUE TO A HISTORY OF ISSUES WITH THEIR ON-SITE ATELLICA IM SYSTEM. FOR THIS SAMPLE, RESULTS FROM THE ATELLICA IM INSTRUMENT WERE CONSISTENT, BUT RESULTS FROM TESTING ON THE ATELLICA CI 1900 INSTRUMENT WERE NOT; ONE FALSELY ELEVATED RESULT WAS IDENTIFIED. 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 23025633 ↗
• MalfunctionSep 11, 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 THCG LOT 362. A DISCORDANT ELEVATED THCG RESULT WAS OBSERVED AMONG A SERIES OF TESTS FOR ONE PATIENT. THE SAMPLE WAS TESTED MULTIPLE TIMES, ON TWO INSTRUMENTS, DUE TO A HISTORY OF ISSUES WITH THEIR ON-SITE ATELLICA IM SYSTEM. FOR THIS SAMPLE, RESULTS FROM THE ATELLICA IM INSTRUMENT WERE CONSISTENT, BUT RESULTS FROM TESTING ON THE ATELLICA CI 1900 INSTRUMENT WERE NOT; ONE FALSELY-ELEVATED RESULT WAS IDENTIFIED. 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 23025599 ↗
• MalfunctionJun 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM TOTAL HCG (THCG) RESULT FOR A MALE CANCER PATIENT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING THCG LOT 363. AN INITIAL ELEVATED ATELLICA IM THCG RESULT WAS OBTAINED FOR A MALE PATIENT UNDERGOING TREATMENT FOR TESTICULAR CANCER. THIS INITIAL RESULT WAS QUESTIONED BY THE PHYSICIAN AND THE TEST WAS REPEATED TWICE; BOTH REPEAT TESTS PRODUCED MUCH LOWER RESULTS (<2.0 MIU/ML). THE LOWER RESULTS WERE ACCEPTED AS CORRECT, AS THEY WERE CONSISTENT WITH PATIENT HISTORY. 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 22193417 ↗
• MalfunctionMar 12, 2025High 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 LOT: THCG 361. DISCORDANCE WAS IDENTIFIED FOR FIVE (5) PATIENTS IN REPEAT TESTING USING ATELLICA IM THCG. ELEVATED THCG RESULTS WERE OBSERVED FOR SEVERAL PATIENTS; THESE RESULTS WERE REPRODUCIBLE IN DUPLICATE TESTING. ONE OF THESE RESULTS WAS QUESTIONED BY A PHYSICIAN, AS TESTING USING ANOTHER PLATFORM HAD PRODUCED A ¿NEGATIVE¿ RESULT FOR THAT PATIENT. AS A RESULT, THCG TESTING WAS REPEATED FOR ALL SAMPLES WHICH HAD BEEN TESTED ON THAT DAY. REPEAT TESTING PERFORMED THE FOLLOWING DAY USING A FRESH SAMPLE ALIQUOT AND A NEW REAGENT PACK PRODUCED MUCH LOWER RESULTS (WITHIN OR BELOW THE REFERENCE RANGE FOR NON-PREGNANT FEMALES), WHICH WERE CONSIDERED CONSISTENT WITH CLINICAL EXPECTATION. 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 21583688 ↗
• MalfunctionJan 14, 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 360. AN INITIAL ELEVATED RESULT (ABOVE REFERENCE INTERVAL) WAS OBTAINED FOR A FEMALE PATIENT IN HER 40S. THE PATIENT TOOK A HOME PREGNANCY TEST, WHICH PRODUCED A NEGATIVE RESULT. FOLLOWING THIS, ADDITIONAL TESTING WAS PERFORMED. TESTING OF BOTH THE ORIGINAL AND NEW SAMPLES, USING BOTH THE ORIGINAL REAGENT LOT AND USING LOT 362, PRODUCED MUCH LOWER RESULTS WHICH WERE ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT EFFECTS, NOR OF ANY DIAGNOSTIC DELAY, IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149159 ↗
• MalfunctionJan 8, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED PATIENT RESULT WITH ATELLICA IM TOTAL HCG (THCG) LOT 361 THAT WAS DISCORDANT RELATIVE TO A RETEST RESULT. THE INITIAL RESULT WAS ABOVE THE EXPECTED REFERENCE INTERVAL/EXPECTED RANGE BUT <5000 IU/L. THE ELEVATED RESULT WAS REPORTED, QUESTIONED BY THE PHYSICIAN AND RETESTED. THE RETEST RESULT WAS BELOW THE REFERENCE INTERVAL/EXPECTED RANGE AND FIT WITH CLINICAL PICTURE OF THE PATIENT. A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. 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 21102565 ↗
• MalfunctionJan 7, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ATELLICA IM TOTAL HCG (THCG) LOT 360 PATIENT SAMPLE RESULT THAT WAS DISCORDANT RELATIVE TO RETEST RESULTS USING THE SAME SAMPLE AS WELL AS ADDITIONAL SAMPLE DRAWS FROM THE PATIENT. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. ADDITIONAL SAMPLES FROM THE SAME PATIENT WERE DRAWN ON DIFFERENT DAYS AND TESTED AND THE RESULTS WERE LOWER. THE CUSTOMER ALSO RETESTED BOTH THE INITIAL SAMPLE AND THE 2ND SAMPLE AND BOTH RESULTS WERE LOW. 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 21095599 ↗
• MalfunctionOct 3, 2023High Test Results; High Test Results

  A FALSELY ELEVATED TOTAL HCG (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1600 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS RUN AT ANOTHER LABORATORY USING AN ALTERNATE METHOD AND THE RESULT WAS LOWER. THE SAMPLE WAS THEN REPEATED ON THE INITIAL AND ALTERNATE ATELLICA IM 1600 ANALYZER. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULT. A CORRECTED REPORT WAS ISSUED. 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 17865351 ↗
• MalfunctionAug 31, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM THCG RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. THCG KIT LOT 348 WAS IN USE AT THE TIME. THE CUSTOMER OBSERVED THCG RESULT DISCORDANCE FOR TWO PATIENTS, WHERE THE INITIAL RESULTS WERE ELEVATED RELATIVE TO LATER REPEAT TESTING USING THE SAME REAGENT LOT. THE LOWER RESULTS WERE CONSISTENT WITH EXPECTATION AND CONSIDERED CORRECT. 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 17663355 ↗
• MalfunctionAug 31, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM THCG RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THCG KIT LOT 348 WAS IN USE AT THE TIME. THE CUSTOMER OBSERVED THCG RESULT DISCORDANCE, WHERE THE INITIAL RESULT WAS ELEVATED RELATIVE TO LATER REPEAT TESTING USING A DIFFERENT REAGENT LOT. THE LOWER RESULT WAS CONSISTENT WITH EXPECTATION AND CONSIDERED CORRECT. 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 17663352 ↗
• MalfunctionFeb 21, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ELEVATED ATELLICA IM TOTAL HCG RESULT FOR ONE PATIENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS REMEASURED ON THE SAME ATELLICA IM SYSTEM AND ANOTHER ATELLICA IM SYSTEM, AND THE RESULTS WERE LOWER. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATELLICA IM TOTAL HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16410147 ↗
• MalfunctionFeb 21, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ELEVATED ATELLICA IM TOTAL HCG RESULT FOR ONE PATIENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS REMEASURED ON THE SAME ATELLICA IM SYSTEM AND ANOTHER ATELLICA IM SYSTEM, AND THE RESULTS WERE LOWER. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATELLICA IM TOTAL HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16410146 ↗
• MalfunctionFeb 9, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ELEVATED ATELLICA IM TOTAL HCG RESULT FOR ONE PATIENT. THE SAMPLE WAS REMEASURED ON ANOTHER ATELLICA IM SYSTEM, AND THE RESULT WAS SAME. REPEAT TESTING WAS DONE ON ALTERNATE METHODS - ALL NEGATIVE FOR TOTAL HCG. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATELLICA IM TOTAL HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16334269 ↗
• MalfunctionFeb 9, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED A DISCORDANT ELEVATED ATELLICA IM TOTAL HCG RESULT FOR ONE PATIENT. THE SAMPLE WAS REMEASURED ON ANOTHER ATELLICA IM SYSTEM, AND THE RESULT WAS SAME. REPEAT TESTING WAS DONE ON ALTERNATE METHODS - ALL NEGATIVE FOR TOTAL HCG. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATELLICA IM TOTAL HCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16334266 ↗
• MalfunctionJul 1, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED RESULT WITH A PATIENT SAMPLE WITH ATELLICA IM TOTAL HCG LOT 338. THE RESULT WAS REPORTED TO THE PHYSICIAN AND THE PHYSICIAN QUESTIONED THE INITIAL RESULT. THE SAMPLE WAS RERUN ON THE ATELLICA IM AND ON AN ALTERNATE PLATFORM. THE REPEAT TESTING ON THE ATELLICA IM AND THE ALTERNATE PLATFORM YIELDED LOWER RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, TOTAL HCG, RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14885082 ↗
• MalfunctionOct 7, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT WITH THE CALIBRATION OF THE NEW ATELLICA IM TOTAL HCG (THCG) REAGENT LOT 334 AND NEW CALIBRATOR CB 099, HIGH QUALITY CONTROL RESULTS AND DISCORDANT PATIENT RESULTS WERE OBSERVED WITH LOT 334 COMPARED TO LOT 329. THE RESULTS FOR REAGENT LOT 334 WERE REPORTED TO THE PHYSICIAN(S), BUT NOT QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, TOTAL HCG, RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590444 ↗
• MalfunctionSep 16, 2021High Test Results; High Test Results

  A FALSELY ELEVATED ATELLICA IM TOTAL HCG (THCG) ASSAY PRE-DILUTION (1:5) RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE AND REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE ELEVATED RESULT COMPARED TO THE PATIENT'S PREVIOUSLY LOWER THCG TEST RESULT (SAMPLE 1). THE CUSTOMER PERFORMED REPEAT NEAT (UNDILUTED) THCG TESTING ON SAMPLE 2, RESULTING LOWER. THE LOWER REPEAT THCG RESULT WAS REPORTED TO THE PHYSICIAN AS THE CORRECT RESULT. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ATELLICA IM THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481182 ↗
• MalfunctionSep 16, 2021High Test Results; High Test Results

  A FALSELY ELEVATED (POSITIVE) ATELLICA IM TOTAL HCG (THCG) ASSAY RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE AND REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE ELEVATED (POSITIVE) RESULT COMPARED TO AN LOWER (NEGATIVE) ALTERNATE QUALITATIVE TEST METHOD RESULT. THE CUSTOMER PERFORMED REPEAT THCG TESTING, RESULTING LOWER (NEGATIVE). A SECOND SAMPLE WAS DRAWN AND THE THCG RESULT WAS LOWER (NEGATIVE). THE LOWER (NEGATIVE) THCG RESULT WAS REPORTED TO THE PHYSICIAN AS THE CORRECT RESULT. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ATELLICA IM THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481180 ↗
• MalfunctionMay 4, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED AN ATELLICA IM TOTAL HCG (THCG) RESULT OF 411.1 MIU/ML FOR ONE PATIENT WHICH WAS CONSIDERED INCONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION. REPEAT TESTINGUSING AN ALTERNATE METHOD AT ANOTHER LABORATORY PRODUCED A RESULT OF <25 MIU/ML. THERE ARE NO ALLEGATIONS OF PATIENT HARM OR CHANGES IN TREATMENT RESULTING FROM THE DISCORDANT THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11771217 ↗
• MalfunctionDec 5, 2020High Test Results; High Test Results

  A CUSTOMER HAS REPORTED A DISCORDANT, ELEVATED RESULT SEEN FOR ONE PATIENT WHEN USING THE ATELLICA IM TOTAL HCG (THCG) ASSAY. THIS RESULT WAS DISCORDANT RELATIVE TO LOWER REPEAT-TEST RESULTS OBTAINED USING THE SAME REAGENTS ON TWO INSTRUMENT SYSTEMS. THE LOWER RESULTS WERE CONSIDERED CONSISTENT WITH THE PATIENT'S MEDICAL HISTORY AND CLINICAL PICTURE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT THCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10953210 ↗
• MalfunctionJan 6, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE LOW ATELLICA IM TOTAL HCG (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS HIGHER. THE PATIENT SAMPLE WAS REPEATED ON THE SECOND ATELLICA IM ANALYZER AND THE RESULT WAS HIGHER AND CONSISTENT WITH THE FIRST REPEAT RESULT. THE CORRECT RESULT WAS RELEASED TO THE PATIENT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOTAL HCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9555673 ↗
• MalfunctionDec 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT HIGH ATELLICA IM TOTAL HCG (THCG) RESULTS WERE OBTAINED FOR A PATIENT WHEN COMPARED TO ANOTHER ATELLICA IM INSTRUMENT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOTAL HCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9526224 ↗
• MalfunctionDec 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT HIGH ATELLICA IM TOTAL HCG (THCG) RESULTS WERE OBTAINED FOR A PATIENT WHEN COMPARED TO ANOTHER ATELLICA IM INSTRUMENT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOTAL HCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9526217 ↗