Atellica Sample Handler Prime 11069001Recalls & reported problems

Summary

The FDA's MAUDE database contains 146 adverse event reports that list this exact device (DI 00630414002439), received between Mar 6, 2018 and Feb 17, 2026 — classified as 1 death, 3 injuries, 142 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (29 reports).

1 FDA recall record name this device's identifier.

7 other recalls cover devices cleared under the same FDA submission (K161954); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 26, 2018Terminated

   When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers

   Z-1587-2018 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 146 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Improper or Incorrect Procedure or Method

  THE CUSTOMER REPORTED THAT THE BARCODE OF THE SAMPLE WITH THE SAMPLE IDENTIFIER (SID) (B)(6) WAS READ BY THE ATELLICA SAMPLE HANDLER TUBE CHARACTERIZATION STATION (TCS) AS SID (B)(6) CAUSING A SAMPLE IDENTIFIER (SID) MISMATCH FAILURE. THE CUSTOMER NOTICED 2 DIFFERENT SETS OF RESULTS FOR PATIENT WITH SID (B)(6). THERE WERE 3 MINUTES BETWEEN THE 2 RESULTS USING DIFFERENT RACK NUMBERS AND POSITION RECORDS. SAMPLE ID (B)(6), FIRST RESULTS FROM LINE 1 WERE CORRECT. SECOND SET OF RESULTS 3 MIN LATER FROM LINE 2 WERE NOT CORRECT AND FROM A DIFFERENT PATIENT WITH SID (B)(6). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE SID MISMATCH FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363209 ↗
• MalfunctionDec 19, 2025Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT A FEW DROPS OF THE CONTENTS OF THE POSITIVE HUMAN IMMUNODEFICIENCY VIRUS, HIV AG/AB QUALITY CONTROL (CHIV QC) MATERIAL SPLASHED ONTO THE OPERATOR¿S HAND AND FACE WHILE LOADING QC MATERIAL ONTO THE ATELLICA SAMPLE HANDLER PRIME. THE OPERATOR WAS NOT WEARING THE APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) AND IS SUSPECTED TO BE PREGNANT. SUBSEQUENTLY, THE CUSTOMER DISINFECTED HERSELF AND THOROUGHLY WASHED HER HANDS AND FACE AND DID NOT REQUIRE MEDICAL ATTENTION. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848275 ↗
• MalfunctionDec 8, 2025Fire; Fire

  AN OUTSIDE THE UNITED STATES CUSTOMER REPORTED AN ATELLICA SAMPLE HANDLER PRIME WAS DIRECTLY AFFECTED BY FIRE. THERE WERE NO INJURIES REPORTED. THERE WAS NO DELAY IN PATIENT TESTING REPORTED AS THIS FACILITY IS A FORENSIC LABORATORY. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744920 ↗
• MalfunctionOct 27, 2025Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED SUSTAINING A CUT ON THEIR RING FINGER WHILE ATTEMPTING TO ADJUST THE SPRINGS ON THE UNDERSIDE OF THE SAMPLE HANDLER DRAWER, WHICH WAS NOT CLOSING PROPERLY ON AN ATELLICA SAMPLE HANDLER PRIME. THE CUSTOMER WAS SENT TO THE EMERGENCY ROOM (ER), WHERE THE WOUND WAS CLEANED AND GLUED TOGETHER WITH A MEDICAL-GRADE ADHESIVE MATERIAL. THE CUSTOMER RECOVERED WITH NO LASTING EFFECTS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: Laceration(s)

  MAUDE report 23389134 ↗
• MalfunctionJun 23, 2025Loss of Power; Loss of Power

  AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED SIEMENS TO REPORT THAT THE ATELLICA SAMPLE HANDLER (SH) LOST POWER AND STOPPED WORKING. SAMPLES WERE NOT GETTING TRANSFERRED TO THE ANALYZER. AN ALTERNATE ATELLICA SOLUTION WITH AN ATELLICA SH WAS AVAILABLE TO CONTINUE LABORATORY OPERATIONS. THERE ARE NO REPORTS OF HARM DUE TO THE LOSS OF POWER AT THE ATELLICA SH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309273 ↗
• MalfunctionJun 9, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT WHILE TROUBLESHOOTING THE JAMMED MOVING CARRIER ON AN ATELLICA SAMPLE HANDLER PRIME, THE OPERATOR PINCHED THEIR KNUCKLE. THE OPERATOR OBSERVED A TUBE OBSTRUCTING THE MAGLINE NEAR THE TUBE CHARACTERIZATION STATION (TCS). THE OPERATOR REMOVED THE TUBE AND ATTEMPTED TO MOVE THE PUCKS AWAY FROM THE GATES. WHILE MOVING PUCKS THROUGH THE BACK OF THE MAGLINE BEHIND THE DECAPPER, TWO PUCKS SNAPPED TOGETHER AND PINCHED THEIR KNUCKLE. THIS CAUSED A SMALL CUT ON THEIR HAND. THE OPERATOR DID NOT SEEK ANY MEDICAL TREATMENT OR INTERVENTION, AND THE OPERATOR WAS WORKING FINE. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165565 ↗
• MalfunctionMar 3, 2025Electrostatic Discharge; Electrostatic Discharge

  THE CUSTOMER REPORTED THAT AN OPERATOR OBTAINED A SHOCK WHEN SHE TOUCHED THE LOWER LEFT BACK PLATE OF THE ATELLICA SAMPLE HANDLER PRIME INSTRUMENT. THE CUSTOMER ALLEGED THAT AS A RESULT OF THE SHOCK, THE OPERATOR EXPERIENCED PAIN IN HER LEFT ARM. UPON FURTHER CLARIFICATION, THE CUSTOMER INFORMED SIEMENS THAT THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND IS FINE. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509839 ↗
• MalfunctionNov 22, 2024Sparking; Sparking

  THE CUSTOMER REPORTED THAT WHEN ATTEMPTING TO OPEN THE DRAWER 1 OF THE ATELLICA SAMPLE HANDLER PRIME, THEY OBSERVED A SPARK FLASH BENEATH THE DRAWER. THERE WAS NO VISIBLE SMOKE OR FLAMES DUE TO THE EVENT. THE CUSTOMER DID NOT EXPERIENCE AN ELECTRIC SHOCK, AND NO INJURY WAS REPORTED DUE TO THE EVENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756931 ↗
• MalfunctionNov 7, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT SAMPLES WERE NOT PROCESSED ON THE ATELLICA SAMPLE HANDLER PRIME SYSTEM WITH SERIAL NUMBER (B)(6). THE CUSTOMER STATED THAT SAMPLE TUBES SENT BY THE LAS (LABORATORY AUTOMATION SYSTEM) TO THE ATELLICA SYSTEM DID NOT RESULT AND RETURNED TO THE LAS. THE CUSTOMER ALLEGES THAT THE AFFECTED TUBES WERE PLACED IN THE LAS STORAGE AND DISPOSED OF AFTER FIVE DAYS WITHOUT ANY RESULTS REPORTED. 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 20635718 ↗
• MalfunctionOct 29, 2024Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT A SAMPLE TUBE IDENTIFIED AS (B)(6) WAS MISREAD AS (B)(6) ON THE ATELLICA SAMPLE HANDLER PRIME. THE SAMPLE WAS UNLOADED INTO OUTPUT DRAWER 3 DUE TO NO ORDERS BEING RECEIVED BY THE LABORATORY INFORMATION SYSTEM (LIS). THE CUSTOMER MANUALLY CHECKED THE PRINTED SAMPLE TUBE IDENTIFIER (SID) ON THE TUBE AND DETERMINED IT DID NOT MATCH THE SID ON THE USER INTERFACE WINDOW (UIW), WHICH WAS (B)(6). NO ERRONEOUS RESULTS WERE REPORTED AGAINST SID (B)(6). 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 20561773 ↗
• MalfunctionOct 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT A PEDIATRIC SAMPLE (SID (B)(6) WAS MISREAD AND PROCESSED AGAINST A DIFFERENT SAMPLE (SID (B)(6) ON THE ATELLICA SAMPLE HANDLER PRIME SYSTEM WITH SERIAL NUMBER (B)(6). THE CUSTOMER STATED THE ISSUE OCCURRED ON (B)(6) 2024 AT 11:15 AM AND THAT SID (B)(6) WAS FRONT-LOADED AND IDENTIFIED AS SID (B)(6), AND THE WORKLIST FOR SID 59249085 WAS PROCESSED. THE CUSTOMER INFORMED SIEMENS THAT THE INCORRECT RESULTS HAD BEEN RELEASED AND WERE QUESTIONED BY THE PHYSICIAN(S). THE CUSTOMER STATED THAT THERE WAS A DELAY IN ANALYSIS BECAUSE THE LIMITED PEDIATRIC SAMPLE VOLUME DEPLETED AND DECIDED NOT TO REBLEED THE INFANT UNTIL THE NEXT DAY. THE CUSTOMER HAS PERFORMED REPEAT TESTING AND ISSUED A CORRECTED REPORT.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 20483122 ↗
• MalfunctionAug 14, 2024No Device Output; No Device Output

  THE CUSTOMER REPORTED AUTO CHECK FAILED ON THE ATELLICA SAMPLE HANDLER PRIME. WHEN THE AUTO CHECK WAS REPEATED, THE LABORATORY INFORMATION SYSTEM (LIS) WAS NOT CONNECTED, AND A STAT SAMPLE WAS NOT PROCESSED. THE CUSTOMER REPORTED THAT SINCE THE ANALYZER APPEARED UNAVAILABLE, A PATIENT WAS REPORTEDLY TRANSFERRED TO ANOTHER HOSPITAL. NO FURTHER DETAILS WERE PROVIDED. THE DURATION OF THE DELAY AND IMPACT TO PATIENT CARE ARE UNKNOWN. THIS MDR IS BEING FILED IN AN ABUNDANCE OF CAUTION.

  Patient problems: Insufficient Information

  MAUDE report 19986380 ↗
• MalfunctionAug 13, 2024Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT WHILE DETERMINING WHY THE VESSEL MOVER MODULE (VMM) ON THE ATELLICA SAMPLE HANDLER PRIME UNEXPECTEDLY HALTED, THE OPERATOR REMOVED CARRIERS FROM THE INSTRUMENT. AS THE OPERATOR REMOVED THE MAGNETIC CARRIERS FROM THE VMM, THE OPERATOR PINCHED HER FINGERS BETWEEN THE CARRIERS. THE OPERATOR REPORTEDLY BRUISED HER RING AND MIDDLE FINGERS, CAUSING THEM TO SWELL; ADDITIONALLY, THE CUSTOMER SHARED THAT THERE WAS A BLISTER ON THE OPERATOR¿S MIDDLE FINGER. THE OPERATOR WENT TO THE EMERGENCY ROOM (ER), WHERE HER FINGER WAS ICED AND BANDAGED. ADDITIONALLY, THE OPERATOR WAS GIVEN ANTI-INFLAMMATORY MEDICATION AND AN ANTIBACTERIAL LOTION. THERE WAS NO EXPOSURE TO BIOHAZARDOUS MATERIAL. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: Laceration(s)

  MAUDE report 19977551 ↗
• MalfunctionJul 23, 2024Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT A SAMPLE TUBE IDENTIFIER WAS MISREAD BY THE TUBE CHARACTERIZATION STATION (TSC) ON THE ATELLICA SAMPLE HANDLER PRIME. THE SAMPLE LABELLED WITH (B)(6) WAS IDENTIFIED AS (B)(6) BY THE TSC. THE CUSTOMER RETESTED THE SAMPLE WITH IDENTIFIER (B)(6) AND PROCESSED THE CORRECT OPEN ORDERS ACCORDINGLY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809529 ↗
• MalfunctionJul 12, 2024Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT SAMPLE TUBE IDENTIFIED WITH SAMPLE IDENTIFIER (B)(6) WAS IDENTIFIED AS (B)(6) BY THE ATELLICA SAMPLE HANDLER PRIME AND THIS BEHAVIOR CAUSED THE RESULTS FOR (B)(6) TO BE ASSOCIATED WITH (B)(6) . NO INCORRECT RESULTS WERE REPORTED. AT THE TIME OF THE MISIDENTIFICATION, ONLY THE FILE FOR (B)(6) WAS CREATED; (B)(6) WAS NOT ASSIGNED TO ANY PATIENT SAMPLE TUBE. SUBSEQUENTLY, CORRECT RESULTS GENERATED FOR BOTH SAMPLES WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE SAMPLE TUBE MISIDENTIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735629 ↗
• MalfunctionJul 3, 2024Sparking; Sparking

  THE CUSTOMER REPORTED THAT THE BARCODE PRINTER OF THE ATELLICA SAMPLE HANDLER PRIME STOPPED PRINTING AND THE CUSTOMER WAS UNABLE TO PRINT A BARCODE. AS A RESULT, THE CUSTOMER UNPLUGGED THE PRINTER. WHEN THE CUSTOMER ATTEMPTED TO RECONNECT THE PRINTER, THE CUSTOMER REPORTEDLY OBSERVED A SPARK. THERE ARE NO KNOWN REPORTS OF FLAMES, SMOKE, NOR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19671072 ↗
• MalfunctionApr 18, 2024Sparking; Sparking

  THE CUSTOMER REPORTED THAT AFTER LOADING A SAMPLE ON THE ATELLICA SAMPLE HANDLER PRIME, AN OPERATOR OPENED A DRAWER AND DETERMINED IT WAS STUCK MIDWAY. THE CUSTOMER ALSO REPORTED THAT THE OPERATOR OBSERVED SPARKS WHEN THE OPERATOR TRIED TO PULL THE DRAWER FORWARD. THE OPERATOR DID NOT EXPERIENCE AN ELECTRIC SHOCK DUE TO THE EVENT. THE OPERATOR WAS ABLE TO CLOSE THE DRAWER WITHOUT ANY ISSUE. THERE ARE NO KNOWN REPORTS OF VISIBLE FLAMES, SMOKE, NOR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139802 ↗
• MalfunctionMar 29, 2024Sparking; Sparking

  THE CUSTOMER REPORTED THAT AFTER OPENING AND/OR SHUTTING DRAWER 2 ON AN ATELLICA SAMPLE HANDLER PRIME, THE WIRE UNDERNEATH WAS TRAPPED AND SPARKING. THE CUSTOMER STOPPED THE INSTRUMENT AND CLOSED THE DRAWER. THERE WERE NO VISIBLE FLAMES OR SMOKE DUE TO THE INCIDENT. THERE WAS NO INJURY REPORTED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004470 ↗
• MalfunctionJan 22, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE ALANINE AMINOTRANSFERASE P5P (ALTPLC), GAMMA-GLUTAMYL TRANSFERASE (GGT), ENZYMATIC CREATININE_3 (ECRE3), ASPARTATE AMINOTRANSFERASE P5P (ASTPLC), WIDE RANGE C REACTIVE PROTEIN (WRCRP), HEMOLYSIS, ICTERUS, LIPEMIA (H, I, L) AND THYROID STIMULATING HORMONE 3-ULTRA (TSH3UL) RESULTS ASSOCIATED WITH THE SAMPLE IDENTIFIED AS (B)(6) WERE REPORTED AS THE RESULTS FOR THE SAMPLE IDENTIFIED AS (B)(6) WHEN THE TUBE CHARACTERIZATION STATION (TCS) ON AN ATELLICA SAMPLE HANDLER PRIME MISREAD THE BARCODE. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE CUSTOMER REPEATED THE SAMPLE IDENTIFIED AS (B)(6). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18559636 ↗
• MalfunctionJan 19, 2024Use of Device Problem; Use of Device Problem

  PATIENT HEPATITIS B SURFACE ANTIGEN (HBSAG) (HBSII) SAMPLES WERE TESTED WHEN QUALITY CONTROLS WERE NOT PROCESSED WITHIN THE CUSTOMER SET TIME LIMIT OF 24 HOURS ON AN ATELLICA SAMPLE HANDLER PRIME. THE INITIAL RESULTS OF NEGATIVE WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER STATED THAT THE REDRAW OF THE PATIENTS WAS NOT PERFORMED AT THIS TIME. 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 18547706 ↗
• MalfunctionNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT AN UNAPPARENT DELAY OCCURRED WITH ONE HUMAN CHORIONIC GONADOTROPIN PATIENT RESULT WITH AN ATELLICA SAMPLE HANDLER PRIME INSTRUMENT. THE CUSTOMER FOUND THE SAMPLES WERE NOT PROCESSED. THE CUSTOMER CONFIRMED THAT THERE WAS NO IMPACT TO PATIENT CARE DUE TO THE DELAY. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192785 ↗
• MalfunctionNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT AN UNAPPARENT DELAY OCCURRED WITH THREE TROPONIN AND ONE HUMAN CHORIONIC GONADOTROPIN PATIENT RESULTS WITH AN ATELLICA SAMPLE HANDLER PRIME INSTRUMENT. THE CUSTOMER FOUND THE SAMPLES WERE NOT PROCESSED. THE CUSTOMER CONFIRMED THAT THERE WAS NO IMPACT TO PATIENT CARE DUE TO THE DELAY. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192779 ↗
• MalfunctionNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT AN UNAPPARENT DELAY OCCURRED WITH ONE HUMAN CHORIONIC GONADOTROPIN PATIENT RESULT WITH AN ATELLICA SAMPLE HANDLER PRIME INSTRUMENT. THE CUSTOMER FOUND THE SAMPLES WERE NOT PROCESSED. THE CUSTOMER CONFIRMED THAT THERE WAS NO IMPACT TO PATIENT CARE DUE TO THE DELAY. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191620 ↗
• MalfunctionNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT AN UNAPPARENT DELAY OCCURRED WITH THREE TROPONIN AND ONE HUMAN CHORIONIC GONADOTROPIN PATIENT RESULTS WITH AN ATELLICA SAMPLE HANDLER PRIME INSTRUMENT. THE CUSTOMER FOUND THE SAMPLES WERE NOT PROCESSED. THE CUSTOMER CONFIRMED THAT THERE WAS NO IMPACT TO PATIENT CARE DUE TO THE DELAY. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191607 ↗
• MalfunctionNov 10, 2023Unable to Obtain Readings; Unable to Obtain Readings

  AN ATELLICA SAMPLE HANDLER PRIME CUSTOMER NOTED THAT SAMPLE (B)(6) RECEIVED AT 12:39 P.M. ON 31-OCT-2023 WAS NOT PROCESSED AND ANALYZED WITH TNIH (HIGH-SENSITIVITY TROPONIN I) AND CAUSED A DELAY IN THE ASSESSMENT OF THE PATIENT. THE CUSTOMER PERFORMED REPEAT TESTING AND NOTED THAT THE SAMPLE WAS TESTED ON AN ALTERNATE ATELLICA ANALYZER. THE TNIH RESULT WAS OBTAINED AT 16:14 P.M. AND RELEASED FROM THE LAB AT 16:25 P.M. ON 31-OCT-2023. 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 18112592 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161954. One submission often covers many models, so check the product and lot details in each record.

• Z-0496-2025 · Oct 21, 2024 · Open, Classified
  Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Numb
• Z-1421-2020 · Jan 12, 2020 · Open, Classified
  Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
• Z-1301-2019 · Mar 7, 2019 · Terminated
  Atellica Sample Handler Prime, Material Number 11069001
• Z-0783-2019 · Sep 26, 2018 · Terminated
  Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-compo
• Z-0190-2019 · Jun 29, 2018 · Terminated
  Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
• Z-0189-2019 · Jun 29, 2018 · Terminated
  Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
• Z-0191-2019 · Jun 29, 2018 · Terminated
  Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.