Atellica IM ThCGRecalls & reported problems across all models

We found 3 models of Atellica IM ThCG by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 68 adverse event reports in the FDA's MAUDE database, received between May 3, 2019 and Apr 17, 2026 — classified as 68 malfunctions.

The most frequently reported specific device problem is “High Test Results” (53 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Atellica IM ThCG problems

Atellica IM ThCG models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Atellica™ IM ThCG 10995689

  Visual, pregnancy hCG, prescription use
  40 reports
• Atellica™ IM ThCG 10995690

  Visual, pregnancy hCG, prescription use
  27 reports
• Atellica IM ThCG 11206261

  Visual, pregnancy hCG, prescription use
  1 report

Recent Atellica IM ThCG adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 31, 2025High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ATELLICA IM TOTAL HCG (THCG), LOT 360, PATIENT SERUM SAMPLE RESULT THAT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN BECAUSE IT DID NOT MATCH CLINICAL PICTURE OF THE PATIENT. THE SAMPLE WAS RETESTED ON A DIFFERENT ATELLICA IM ANALYZER IN DUPLICATE, AND THE RESULTS WERE LOWER AS EXPECTED. A CORRECTED REPORT WAS ISSUED. 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 21282990 ↗
• 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 ↗

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