Alinity 06P1601Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00380740138479), received between Sep 22, 2019 and Sep 30, 2026 — classified as 9 injuries, 75 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (28 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 3, 2022Open, Classified

   Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.

   Z-0749-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954177 ↗
• MalfunctionFeb 6, 2026Thermal Decomposition of Device

  THE CUSTOMER REPORTED INSTRUMENT ERROR 5600-B317 (¿SAMPLE PIPETTOR GANTRY FAILED¿) ON THE ALINITY S SYSTEM. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THE 6-AXIS BOARD WAS DAMAGED, LIKELY DUE TO LIQUID LEAKING ONTO THE BOARD. THIS LEAK ALSO CAUSED DAMAGE TO SAMPLE MERIDIAN BOARDS 1¿3 AND RESULTED IN A BLOWN FUSE AND CHARRING ON BOTH THE MERIDIAN BOARD AND THE 6-AXIS BOARD CONSISTENT WITH LIQUID EXPOSURE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278137 ↗
• MalfunctionJan 27, 2026Thermal Decomposition of Device

  THE CUSTOMER REPORTED ERROR MESSAGE SAMPLE PROBE 1 Z MOTOR FAILURE ON THE ALINITY'S PROCESSING MODULE. DURING THE SITE VISIT, THE FIELD SERVICE REPRESENTATIVE (FSR) OBSERVED EVIDENCE OF BURNING ON THE CABLE, S R1 CICOIL, WHICH IN BETWEEN THE Z-MOTOR AND 6-AXIS BOARD ON THE ALINITY'S PROCESSING MODULE. THE FSR REPLACED THE AFFECTED CABLE, S R1 CICOIL, WHICH RESOLVED THE ISSUE. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM TO USER REPORTED. NO ADDITIONAL IMPACT TO USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192155 ↗
• MalfunctionOct 8, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HIV AG/AB COMBO GENERATED FROM ALINITY S SYSTEM AND PROVIDED THE FOLLOWING DATA: SAMPLE (B)(6) WAS TESTED AFTER THE HIGH REACTIVE SAMPLE ON ALINITY S SYSTEM SN: (B)(6) AND GENERATED A RESULT OF 56.32 S/CO (REACTIVE). SAMPLE WAS RE-TESTED ONE TIME ON THE SAME ANALYZER AND THREE TIMES ON A DIFFERENT ANALYZER (SN: (B)(6) AND GENERATED REACTIVE RESULTS. THE CUSTOMER TESTED AN ARCHIVED SAMPLE FROM THE SAME INDIVIDUAL ON SN: (B)(6) AND THE RESULT WAS 0.08 S/CO (NON-REACTIVE). THE CUSTOMER BELIEVES THAT SAMPLE (B)(6) GAVE FALSE REACTIVE RESULTS AND WAS CONTAMINATED BY BEING TESTED DIRECTLY AFTER THE HIGH REACTIVE SAMPLE (SAMPLE (B)(6). PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23243967 ↗
• MalfunctionOct 2, 2025Sparking; Sparking

  THE ABBOTT AMBASSADOR OBSERVED A SPARK ORIGINATING FROM THE SAMPLE MANAGER ICB DURING QUARTERLY MAINTENANCE OF THE ALINITY S SYSTEM. FOLLOWING THE SPARK, THE SYSTEM GENERATED ERROR CODES 5120-B715 (SAMPLE MANAGER ICB-STEPPERPG 36V) SENSOR FAILED, AND 5120-B715 (SAMPLE MANAGER ICB ¿ STEPPERFLT 36V) SENSOR FAILED. NO INJURIES OR HARM TO THE USER WERE REPORTED, AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23199862 ↗
• MalfunctionMay 29, 2025Smoking; Smoking

  DURING INSTALLATION OF THE ALINITY S PROCESSING MODULE, THE CUSTOMER OBSERVED SMOKE. THE INSTRUMENT WAS POWERED OFF. NO IMPACT TO USER SAFETY OR PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104746 ↗
• MalfunctionMay 16, 2025Sparking; Sparking

  THE CUSTOMER OBSERVED SPARKS WHEN THEY TRIED TO PLUG THE UPS BACK INTO THE WALL OUTLET CONNECTED TO THE ALINITY S PROCESSING MODULE. THE CUSTOMER DOING TROUBLESHOOTING FOR LOST POWER AND NOTICED NO POWER TO UPS. THE SPARK WAS OBSERVED AT THE TIME WHEN UNPLUGGED AND RECONNECTED THE UPS TO THE WALL OUTLET. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM TO USER REPORTED. NO ADDITIONAL IMPACT TO USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035977 ↗
• MalfunctionMay 15, 2025Leak/Splash; Leak/Splash

  AN ABBOTT EMPLOYEE REPORTED A SPLASH TO THE FACE WHILE PERFORMING MAINTENANCE ON THE ALINITY S PROCESSING MODULE. WHILE CLEANING THE SAMPLE PROBE WASH STATION WITH A BRUSH, SALINE WAS SPRAYED OFF THE BRUSH, AND DROPLETS ENTERED THE EMPLOYEE¿S MOUTH. THE EMPLOYEE FLUSHED HER ORAL CAVITY WITH WATER. THE EMPLOYEE WAS TREATED FOR POSSIBLE EXPOSURE TO INFECTIOUS MATERIAL AT THE EMERGENCY DEPARTMENT WITH AN EXAMINATION BY THE ATTENDING PHYSICIAN AND ROUTINE BLOODWORK. THERE WAS NO OTHER FURTHER FOLLOW UP. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027659 ↗
• MalfunctionApr 28, 2025Thermal Decomposition of Device; Smoking; Sparking; Thermal Decomposition of Device; Smoking; Sparking

  SPARKS AND SMOKE WERE REPORTED COMING FROM AN ALINITY S SYSTEM. IT WAS REPORTED THAT THE ANALYZER WAS DOWN FOR RSM THETA MOTOR FAILURE ON 8 APR 2025 WHEN THE SPARKS AND SMOKE OCCURRED. UPON INSPECTION ON 9 APR 2025 BY FIELD SERVICE ENGINEER, FLUID/CONTAMINATION WAS NOTED AND THE RSM THETA MERIDIAN CONTROLLER HAD BURN MARKS. MULTIPLE ANALYZER PARTS WERE REPLACED. THERE WERE NO INJURIES AND NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922497 ↗
• InjuryMar 13, 2025Use of Device Problem; Use of Device Problem

  WHILE CLEANING A PROBE ON THE ALINITY S SYSTEM, THE PROBE WENT THROUGH GLOVE OF A FIELD SERVICE ENGINEER (FSE) AND CUT THEIR HAND. THE CUT WAS IMMEDIATELY WASHED WITH SOAP, STERILIZED WITH ALCOHOL, AND A BANDAGE WAS PLACED. IT WAS REPORTED THAT THE INSTRUMENT WAS OFFLINE WHEN THE EVENT OCCURRED. THE INDIVIDUAL WENT TO AN EMERGENCY DEPARTMENT ON (B)(6) 2025. COMPLETE METABOLIC PANEL, HIV, HEPATITIS C, AND HBSAG LABORATORY TESTS WERE PERFORMED. NO RESULTS WERE PROVIDED. THE INDIVIDUAL WAS STARTED ON EMTRICITABINE TENOFOVIR AND RALTEGRAVIR FOR HIV EXPOSURE PROPHYLAXIS. THE INDIVIDUAL WAS INSTRUCTED TO FOLLOW UP WITH OCCUPATIONAL HEALTH FOR ANY FURTHER CARE, SUCH AS RECHECKING LABORATORY TESTING.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21599259 ↗
• MalfunctionFeb 7, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER REPORTED ERROR MESSAGES 5209 (SAMPLE Z2 MTR COMM BAD STATE) AND ZIP 5V SUPPLY OVERLOAD ON THE ALINITY S SYSTEM. NO FIRE OR SMOKE WAS OBSERVED. THE AMBASSADOR INSPECTED THE INSTRUMENT AND NOTICED A BLACKENED CABLE IN THE CICOIL CABLE TO THE Z2 MOTOR. ADDITIONALLY, THE MERIDIAN CONTROLLERS ON 6-AXIS BOARDS WERE BLINKING RED. THE AMBASSADOR REPLACED THE DAMAGED SAMPLE 2 CICOIL CABLE, RESOLVING THE ISSUE. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337015 ↗
• MalfunctionDec 20, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER OBSERVED SEVERAL INSTRUMENT ERROR MESSAGES ON AN ALINITY S ANALYZER. WHILE THE AMBASSADOR WAS TROUBLESHOOTING THE ISSUES, CHARRING WAS OBSERVED ON THE CICOIL CABLE, WHICH WAS REPLACED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT, USER SAFETY, OR FACILITY DAMAGE REPORTED. THERE WERE NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20993602 ↗
• MalfunctionDec 16, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  DURING INSTALLATION OF THE ALINITY S SYSTEM, A MESSAGE WAS OBSERVED INDICATING THE BULK SOLUTION DRAWER WAS OFFLINE, AND THE INSTRUMENT TRANSFERRED TO THE STOPPED POSITION. IT WAS OBSERVED THAT THERE WAS NO POWER TO THE BOARD, AND THERE WAS DAMAGE TO THE BOARD POWER CABLE. ONE OF THE RED CABLES IN THE CABLE BUNDLE WAS BLACKENED (CHARRED) AND SEPARATED INTO TWO PIECES. AFTER CABLE REPLACEMENT IT STARTED TO WORK NORMALLY. NO INJURY TO THE USER WAS REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20938471 ↗
• MalfunctionDec 9, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER OBSERVED Z1 MOTOR COMMUNICATION ERRORS GENERATED ON THE ALINITY S SYSTEM. THE INSTRUMENT WHEN TRYING TO REINITIALIZE, IT INSTANTLY WENT INTO STOP MODE. THE FIELD SERVICE REPRESENTATIVE (FSR) ARRIVED ONSITE TO INSPECT THE INSTRUMENT AND NOTICED THAT THE SAMPLE PROBE 1 CICOIL WAS BURNT/CHARRED. THE FSR REPLACED THE SAMPLE Z1 CICOIL. WHILE RUNNING PIPETTOR CALIBRATION TARGET LOCATION CHECK, SAMPLE Z2 FAILED. NOTICED THAT IT WAS MAKING A LOUD SOUND WHILE MOVING. THE FSR REPLACED THE SAMPLE Z2 MOTOR. THERE WAS NO HARM OR INJURIES REPORTED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20887204 ↗
• MalfunctionJul 16, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER REPORTED A LOUD POP SOUND COMING FROM THE ALINITY S (SN: (B)(6)) FOLLOWED BY A BURNING SMELL AND LOSS OF POWER TO THE ENTIRE INSTRUMENT. THE CIRCUIT BREAKER FOR THE ANALYZER TRIPPED. THE ANALYZER WAS UNPLUGGED AND UPON ASSESSMENT THE BURNING SMELL WAS COMING FROM THE POWER SUPPLY AREA. THE 48 VOLT POWER SUPPLY BOARD HAD BURNING / CHARRING THAT EXTENDED ACROSS MULTIPLE COMPONENTS. A NEW POWER SUPPLY WAS INSTALLED, AND THE INSTRUMENT IS NOW POWERING ON AND REPORTEDLY PASSED INITIALIZATION, DAILY MAINTENANCE AND QC. THERE WAS NO REPORTED INJURY RELATED TO THE EVENT AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19756037 ↗
• MalfunctionFeb 22, 2024Misassembled During Installation; Misassembled During Installation

  ABBOTT HAS IDENTIFIED AN ISSUE WHERE AN ABBOTT EXTERNAL WASTE PUMP, NOT INTENDED FOR USE WITH THE ALINITY S SYSTEM, WAS INSTALLED ON SEVEN DISTRIBUTED ALINITY S SYSTEMS. THE ISSUE WAS INITIALLY IDENTIFIED VIA TROUBLESHOOTING OF A HIGH PRESSURE MESSAGE CODE ON A DISTRIBUTED ALINITY S SYSTEM. AN ABBOTT EXTERNAL WASTE PUMP WAS INSTALLED TO RESOLVE THE ISSUE. DURING DOCUMENTATION OF THE ISSUE, IT WAS IDENTIFIED THAT THE EXTERNAL WASTE PUMP IS NOT INTENDED FOR USE WITH THE ALINITY S SYSTEM. A FIELD DATA REVIEW CONCLUDED A TOTAL OF SEVEN EXTERNAL AND EIGHT INTERNAL ANALYZERS WITH AN ABBOTT EXTERNAL WASTE PUMP CONNECTED. THERE IS A POTENTIAL FOR LEAKAGE OR FOAMING AT THE EXTERNAL WASTE PUMP(S) WHICH COULD RESULT IN LIQUID ESCAPING THE PUMP ONTO THE FLOOR; THUS, THE POTENTIAL EXISTS FOR A PHYSICAL/OPERATOR INJURY (SLIP / FALL) AND/OR BIOHAZARD EXPOSURE DUE TO LIQUID WASTE ON THE FLOOR AROUND THE EXTERNAL WASTE PUMP(S). THERE HAVE BEEN NO OCCURRENCES OF OPERATOR INJURY OR BIOHAZARD EXPOSURE AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18764259 ↗
• MalfunctionFeb 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DURING TROUBLESHOOTING OF AN ALINITY S SYSTEM, SERIAL NUMBER (B)(6), THE ABBOTT AMBASSADOR REPORTED THAT THE INCUBATION TRACK WAS UNABLE TO FLATLY SEAT ON THE EXISTING INSTRUMENT FRAME STANDOFFS AS THE INSTRUMENT WAS MANUFACTURED WITH INCORRECT STANDOFFS. THERE WAS NO IMPACT TO PATIENT RESULTS, PATIENT MANAGEMENT, OR USER SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18654901 ↗
• MalfunctionFeb 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ABBOTT HAS IDENTIFIED A POTENTIAL ISSUE WITH HARDWARE ASSOCIATED WITH THE ASSEMBLY OF THE ALINITY S SYSTEM INCUBATION TRACK. FOUR STANDOFFS (POSTS) ARE UTILIZED TO ATTACH THE ALINITY S SYSTEM INCUBATION TRACK TO THE SYSTEM FRAME. IN THE INSTANCE IDENTIFIED, TWO OF THE FOUR STANDOFFS WERE FOUND TO BE 5.75 MILLIMETERS ABOVE SPECIFICATION CREATING A SLIGHT (+0.37O) ELEVATION AT ONE END OF THE TRACK. THIS MAY LEAD TO REACTION VESSEL (RV) JAMS AND/OR SPLASHING WITHIN THE RV AS IT TRANSITIONS FROM THE INCUBATION TRACK TO THE PROCESS PATH DURING INSTRUMENT OPERATION. SPLASHING WITHIN AN RV HAS POTENTIAL TO AFFECT TEST RESULTS. THERE HAVE BEEN NO OCCURRENCES OF INCORRECT RESULTS DUE TO THIS ISSUE. A FIFTH STANDOFF IS UTILIZED ON THE ALINITY S SYSTEM TO ATTACH THE RV LOADER TO THE FRAME. THE RV LOADER TRANSITIONS THE RV TO THE INCUBATION TRACK, WHICH IS PRE-ANALYTIC MOVEMENT DURING INSTRUMENT OPERATION. THERE WOULD BE NO IMPACT TO ASSAY TEST RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18654649 ↗
• MalfunctionJan 30, 2024Computer Software Problem; False Positive Result; Computer Software Problem; False Positive Result

  ABBOTT HAS IDENTIFIED TWO POTENTIAL ISSUES THAT MAY OCCUR WHEN OPERATING THE ALINITY S SYSTEM WITH SOFTWARE VERSIONS 2.8.2 (LIST NUMBER 04U76-17) AND PRIOR. THE FOLLOWING ISSUES HAVE BEEN IDENTIFIED: 1) MISASSIGNED SAMPLE PIPETTOR ASPIRATION LOCATIONS AT THE LABORATORY AUTOMATION SYSTEM (LAS) CAN CAUSE RESULTS TO BE WRONGLY ATTRIBUTED TO THE INCORRECT UNIQUE SAMPLE IDENTIFIER (SID). AN INCORRECT LAS ASPIRATION LOCATION CALIBRATION CAN CAUSE MISASSIGNED TEST RESULTS, I.E., THE RESULT ASSIGNED TO THE SID ORIGINATED FROM ANOTHER SID ONBOARD THE INSTRUMENT. THIS ISSUE ONLY IMPACTS THE ALINITY S SYSTEMS WHICH ARE INTEGRATED WITH A LAS. 2) THE PIPETTOR POSITIONING MAY BE OFF TARGET IF A PIPETTOR PROBE IS NOT STRAIGHT OR HOMED CORRECTLY DUE TO UNINTENDED CONTACT BETWEEN THE PIPETTOR OR PIPETTOR PROBE WITH ANOTHER COMPONENT DURING INSTRUMENT OPERATION. SAMPLE PIPETTOR PROBE POSITIONING THAT IS SKEWED 1.5 ¿ 2.0MM CAN CAUSE INACCURATE PIPETTING WITHOUT GENERATING A ROBOTICS AND SENSOR MESSAGE CODE (5000-5999). A BENT OR MISPOSITIONED SAMPLE PIPETTOR PROBE OFF TARGET 1.5 -2.0MM HAS THE POTENTIAL TO AFFECT PIPETTING ACCURACY AND GENERATE FALSE POSITIVE RESULTS. PIPETTOR PROBE POSITIONING OFF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608288 ↗
• MalfunctionNov 10, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ABBOTT HAS IDENTIFIED THE ALINITY S SYSTEM CONTAINS A LATEX SUBCOMPONENT AND IS NOT LABELED AS CONTAINING LATEX. PRECAUTIONARY LABELING IS BEING ADDED TO THE ALINITY S SYSTEM TO INFORM THE USERS OF THE PRESENCE OF DRY NATURAL RUBBER (LATEX). THE ALINITY S SYSTEM SOLID WASTE CONTAINER RUBBER BAND (LN 04U97-01) USED TO SECURE THE BIOHAZARD BAG TO THE SOLID WASTE CONTAINER, AND INTERNAL HARDWARE PARTS AND/OR SUBASSEMBLIES, CONTAIN DRY NATURAL RUBBER (LATEX). DIRECT CONTACT WITH THESE COMPONENTS HAS THE POTENTIAL TO CAUSE ALLERGIC REACTIONS. THERE HAS BEEN NO REPORTED OCCURRENCES OF THE ISSUE TO DATE OF ADVERSE IMPACT OR HARM TO THE USER/OPERATOR AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18111294 ↗
• MalfunctionOct 24, 2023Leak/Splash; Leak/Splash

  ABBOTT HAS IDENTIFIED A POTENTIAL ISSUE WITH ALINITY S SYSTEM (LN 06P16-01). COMMUNICATION WITH THE SUPPLIER (GEMS SENSORS, INC.) IDENTIFIED THAT THE SUPPLIER OF THE PHOTO SENSOR WITHIN THE OPTICAL FLOOD DETECTION SENSOR PART # 30106585-203/ B-30106585-01 WAS CHANGED FROM HONEYWELL TO OPTEK IN 2018. HOWEVER, ABBOTT WAS NOT NOTIFIED OF THIS CHANGE. OPTEK SENSORS HAVE BEEN FOUND TO BE MORE SENSITIVE TO REFLECTIVE AREAS COMPARED TO THE HONEYWELL SENSORS. THE ALINITY S SYSTEM EMPLOYS OPTICAL SENSORS WITHIN SIX LOCATIONS OF THE ALINITY S SYSTEM TO DETECT UNINTENDED LEAKAGE DURING INSTRUMENT OPERATION. REFLECTIVE SURFACES IN THE BULK SOLUTION MANAGEMENT (BSM) AND OPTIONAL ALTERNATE WASH DELIVERY SYSTEM (AWDS) AREAS INHIBIT FUNCTIONALITY OF THE OPTICAL SENSOR IN TWO OF THE SIX LOCATIONS. FAILURE OF THE OPTICAL SENSOR TO DETECT LEAKAGE IN THE BSM AND OPTIONAL AWDS AREAS COULD RESULT IN LIQUID ESCAPING THE INSTRUMENT ONTO THE FLOOR; THUS, THE POTENTIAL EXISTS FOR A PHYSICAL / OPERATOR INJURY (SLIP / FALL) DUE TO LIQUID ON THE FLOOR AROUND THE INSTRUMENT. SINCE THIS ISSUE HAS THE POTENTIAL FOR LEAKAGE TO BE UNDETECTED BY THE ALINITY S SYSTEM IN THE BSM AND AWDS AREAS, IMPLEMENTATION OF A HAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996082 ↗
• InjurySep 29, 2023Use of Device Problem; Use of Device Problem

  THE FIELD SERVICE ENGINEER (FSE) WAS SERVICING AN ALINITY S SYSTEM ON 14 SEP 2023. THE FSE WAS CUT ON THE LEFT HAND BY A WASH ZONE PROBE. THE FSE WAS WEARING A PAIR OF GLOVES AT THE TIME OF THE EVENT. THE CUT MINOR AND THE FSE WASHED AND APPLIED ALCOHOL TO THE AREA. THE FSE WENT TO THE EMERGENCY DEPARTMENT, WHERE BLOOD WORK WAS TAKEN, AND A TETANUS SHOT WAS ADMINISTERED. ON 15 SEP 2023, FSE RETURN TO HOSPITAL FOR AN HB TITER (TO CHECK FOR IMMUNITY) IN ADDITION TO AN HIV PROPHYLAXIS PRESCRIPTION. THE TITER WAS PERFORMED AND FSE WAS PROVIDED A PRESCRIPTION FOR BIKTARVY 50-200-25MG. PRESCRIPTION WAS FILLED AND FSE TOOK HIS FIRST PILL AROUND 6:30P ON 15 SEP 2023. FSE WAS ADVISED THAT SIDE EFFECTS OF THE PRESCRIPTION IS LIVER/KIDNEY DAMAGE AND THAT ADDITIONAL BLOOD WORK IS NEEDED TO MONITOR THOSE ORGANS. THE CUT MINOR AND THE AREA WAS WASHED AND APPLIED ALCOHOL. BLOOD WORK WAS TAKEN, A TETANUS SHOT WAS ADMINISTERED, AND AN HIV PROPHYLAXIS WAS PRESCRIBED. ADDITIONAL BLOOD WORK IS REQUIRED FOR MONITORING. ADDITIONAL LABS WERE DRAWN FOR A COMPREHENSIVE METABOLIC PANEL AND URINE ANALYSIS. HIV TEST IS PLANNED TO BE REPEATED IN 6 MONTHS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17844623 ↗
• MalfunctionJun 9, 2023Leak/Splash; Leak/Splash

  THE FIELD SERVICE ENGINEER (FSE) REPORTED WHILE REMOVING THE TRIGGER WASTE TUBING OF THE ALINITY S PROCESSING MODULE, AS PART OF TROUBLESHOOTING, A SMALL AMOUNT OF TRIGGER SOLUTION WASTE FLICKED INTO THEIR LEFT EYE. THE FSE CLEANED IMMEDIATELY WITH WATER AND NO ISSUES OCCURRED WITH THEIR EYE AFTER CLEANING. NO OTHER INTERVENTION WAS REQUIRED AFTER THE WATER WASH AND THERE WAS NO REPORTED LASTING EFFECTS ON THE EYE. THE FSE REPORTED ONLY GLOVES AND LAB COAT WERE UTILIZED FOR THIS EVENT AND STATED THAT SAFETY GOGGLES WILL BE USED IN FUTURE EVENTS TO MINIMIZE IMPACT. THE INSTRUMENT WAS BEING SERVICED DUE TO THE SAMPLE MANAGER ICB (STEPPERPG 36V) SENSOR THAT FAILURE. ADDITIONALLY, THE FOLLOWING INFORMATION WAS PROVIDED REGARDING THE TROUBLESHOOTING AND SERVICE THAT WAS PERFORMED. THE FSE HAS CHECKED/RESEATED ALL CONNECTIONS ON THE RSM ICB, CHECKED ALL FUSES ON THE PDM, CHECKED ALL THE CONNECTIONS ON THE POWER SUPPLY. SWAPPED THE RSM ICB WITH THE BSM ICB, TESTED ALL MICRO FUSES ON BOTH ICB'S, ERROR CONTINUED. MANUALLY MOVED ALL PIPETTORS, PROCESS PATHS, RSM ROBOT TO A DIFFERENT HOMING POSITION AND TESTED INTERLOCKS, WITH ALL DOORS OPEN/CLOSED WHICH PASSED. A NEW ICB & POWER SUPPLY UNIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097196 ↗
• MalfunctionMay 31, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S ANTI-HBC RESULTS FOR ONE SAMPLE WHILE RUNNING ON THE ALINITY S SYSTEM. THE CUSTOMER STATED A SAMPLE GENERATED AN INITIAL REACTIVE RESULT WHEN RAN ON THE ALINITY S SYSTEM, SERIAL NUMBER (B)(6) AND THEN AFTER REPEATING IN DUPLICATE ON ANOTHER ALINITY S SYSTEM, SERIAL NUMBER (B)(6) , THE RESULTS GENERATED NEGATIVE VALUES. THE CUSTOMER DECIDED TO RUN 2 MORE TESTS ON THE (B)(6) INSTRUMENT AND AGAIN GENERATED REACTIVE RESULTS AGAIN. THEN THE CUSTOMER DECIDED TO REPLACE THE CURRENT ALINITY S ANTI- HBC REAGENT KIT WITH A NEW KIT AND RUN THE SAMPLE AGAIN IN DUPLICATE ON AS1244. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 1.00 S/CO IS NONREACTIVE, >/= 1.00 S/CO IS REACTIVE):ON (B)(6) 2023:INITIAL RESULT ON (B)(6) WITH SID (B)(6) = 1.13 S/CO (REACTIVE); REPEAT RESULT ON (B)(6) WITH SID (B)(6) (SAME PATIENT DIFFERENT SAMPLE ID) = 0.35 AND 0.39 S/CO (NONREACTIVE).THE CUSTOMER THEN DECIDED TO RUN THE SAMPLE AGAIN ON (B)(6) DUE TO CONFLICTING RESULTS ABOVE:SID (B)(6) (SAME PATIENT DIFFERENT SAMPLE ID) = INITIAL RESULT ON (B)(6) = 1.17 S/CO (REACTIVE); REPEATED RESULT ON (B)(6) WITH SID (B)(6) (SAME PATIENT) = 1.10 S/CO (REACTIVE).SERVICE ARRI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035066 ↗
• MalfunctionApr 12, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S ANTI-HCV II RESULTS FOR TWO DONORS. SINCE TWO PLASMA SAMPLES WERE TAKEN FROM EACH DONOR, THE CUSTOMER PERFORMED TESTING ON THE SECOND SAMPLE WHICH GENERATED NONREACTIVE RESULTS. CARRYOVER CONTAMINATION IS SUSPECTED AS THE PRECEDING SAMPLE WAS A REACTIVE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 SID (B)(6): SAMPLE 1 INITIAL ALINITY S ANTI-HCV II RESULT = REACTIVE; REPEAT IN DUPLICATE = BOTH REACTIVE, SINGLE PCR HCV RESULT = POSITIVE. SAMPLE 2 RAN IN TRIPLICATE = ALL NONREACTIVE FOR ALINITY S ANTI-HCV II, SINGLE PCR HCV RESULT = NEGATIVE, HCV-LIA RESULT = NEGATIVE. (B)(6) 2023 SID (B)(6): SAMPLE 1 INITIAL ALINITY S ANTI-HCV II RESULT = REACTIVE; REPEAT IN DUPLICATE = ONE REACTIVE, ONE NONREACTIVE, SINGLE PCR HCV RESULT = POSITIVE. SAMPLE 2 RAN IN TRIPLICATE = ALL NONREACTIVE FOR ALINITY S ANTI-HCV II, SINGLE PCR HCV: NEGATIVE, HCV-LIA: NEGATIVE, NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728852 ↗