Alinity 09P6801Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 00380740138851), received between Sep 13, 2023 and Sep 18, 2026 — classified as 3 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (67 reports).

2 FDA recall records name this device's identifier, 2 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. Sep 18, 2025Open, Classified

   Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.

   Z-0489-2026 · Root cause: Software design · FDA record ↗

2. Jun 14, 2024Open, Classified

   1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts

   Z-2681-2024 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820035 ↗
• MalfunctionSep 17, 2026Low Test Results

  The customer observed falsely depressed Hemoglobin on the Alinity hq Processing Module for one female patient. The following results were provided:(b)(6) 2026, SID (b)(6), initial Hemoglobin results= 78 g/L, 76 g/L; repeat result on a recollected sample= 84 g/L; result from (b)(6) 2026= 84 g/L (reference range 120 to 160 g/L). There was no impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803010 ↗
• MalfunctionAug 24, 2026High Test Results

  The customer reported falsely elevated platelet results generated from Alinity hq and provided the following data:Sample ID (b)(6) platelet results were 73,000, 1,400,000, 490,000 and 490,000 10^3 cells/mL.Sample ID (b)(6) platelet results were 48,000, 1,214,000, 302,000 and 302,000 10^3 cells/mL.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 50411772 ↗
• MalfunctionAug 5, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50144260 ↗
• MalfunctionJul 30, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50086696 ↗
• MalfunctionJul 7, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED HEMOGLOBIN RESULTS ON THE ALINITY HQ PROCESSING MODULE FOR A 62-YEAR-OLD FEMALE. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6), INITIAL HEMOGLOBIN RESULT= 51.5 G/L; REPEAT RESULT= 97.2 G/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25731748 ↗
• MalfunctionJun 29, 2026Low Test Results

  THE CUSTOMER REPORTED A DISCREPANCY IN WHITE BLOOD CELL DIFFERENTIAL RESULTS, WHERE NEUTROPHIL ABSOLUTE COUNTS APPEARED TO BE MISCLASSIFIED AS EOSINOPHIL COUNTS BY THE ALINITY HQ PROCESSING MODULE FOR MULTIPLE PATIENT SPECIMENS. THE RESULTS PROVIDED WERE: ON (B)(6) 2026 ,SID (B)(6) : 21YRS OLD FEMALE: NEUTROPHIL ABSOLUTE=0.003 10E9/L /REPEATED ON ALINITY (B)(6) =6.59 10E9/L. SID (B)(6): 23YRS OLD FEMALE: NEUTROPHIL ABSOLUTE=0.001 10E9/L /REPEATED ON ALINITY (B)(6)=5.22 10E9/L . THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25654003 ↗
• MalfunctionMay 12, 2026Leak/Splash

  AN ABBOTT TECHNICAL SUPPORT SPECIALIST (TSS) WAS SPLASHED IN THE RIGHT EYE WITH DILUTED AUTOCLEAN SOLUTION FROM THE ALINITY HQ PROCESSING MODULE. THE TSS WAS PERFORMING A CLEANING PROCEDURE ON THE INSTRUMENT AND THERE WAS A LEAK BETWEEN THE TUBING AND FITTING. HE RINSED HIS EYE FOR 10 MINUTES AND WAS SEEN BY AN OPHTHALMOLOGIST WHO DETERMINED THERE WAS NO INJURY. 1 DROP OF CARBOXYMETHYLCELLULOSE SODIUM 0.5% WAS PRESCRIBED TO BE ADMINISTERED EVERY THREE HOURS FOR THE FIRST DAY AND EVERY 4 HOURS STARTING THE SECOND DAY UNTIL THE BOTTLE IS EMPTY. THE TSS INDICATED HE HASN'T FELT ANY IRRITATION AFTER THE SECOND DAY. NO ADDITIONAL IMPACT TO THE USER WAS REPORTED.

  Patient problems: Eye Irritation

  MAUDE report 25150537 ↗
• MalfunctionMay 7, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED WBC, HEMOGLOBIN AND NEUTROPHIL RESULTS ON THREE PATIENTS WHEN PROCESSED ON THE ALINITY HQ ANALYZER. THE FOLLOWING DATA WAS PROVIDED. ON (B)(6) 2026, SID (B)(6), MALE, BORN IN 1967; WBC= INITIAL RESULT 4.89 & REPEAT RESULTS =15.0 10E3/L, REPEAT RESULTS ON ANOTHER ANALYZER (B)(6) = 14.7 10E3/L. INITIAL HEMOGLOBIN RESULTS WERE 7.59, 15.0 G/DL & REPEAT RESULTS ON ANOTHER ANALYZER (B)(6) = 14.6 G/DL, NEUTROPHIL= INITIAL RESULTS 4.15 & REPEAT RESULTS =12.2 10E3/L, REPEAT RESULTS ON ANOTHER ANALYZER (B)(6) 12.0 10E3/L, RBC= 2.82, 5.29 10E6/L REPEAT RESULTS ON ANOTHER ANALYZER (B)(6) 5.22 10E6/L. ON (B)(6) 2026, SID (B)(6) MALE, BORN IN 1969; WBC = INITIAL RESULT 2.41 & REPEAT RESULT 6.06 10E3/L, RBC (INITIAL, REPEAT) = 4.94,2.92 10E6/, HEMOGLOBIN (INITIAL, REPEAT) =15.1,8.3 G/DL. ON (B)(6) 2026, SID (B)(6), MALE- BORN IN 1938, WBC= INITIAL RESULT 2.99 & REPEAT RESULT 6.39 10E3/L, HEMOGLOBIN = INITIAL RESULT = 7.04, REPEAT RESULT 11.9 G/DL, RBC (INITIAL, REPEAT) = 2.89,3.94 10E6/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110700 ↗
• MalfunctionMay 5, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED WHITE BLOOD COUNT (WBC), HEMOGLOBIN AND RED BLOOD CELL (RBC) RESULTS GENERATED FROM ALINITY HQ PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2026 SID (B)(6): 39YRS OLD MALE: WBC=8.15 10E3/UL /REPEATED =2.35 10E3/UL RBC=5.63 10E6/UL /REPEATED=2.85 10E6/UL HGB =16.6 G/DL /REPEATED=7.79 G/DL PLATELET=250 10E3/UL /REPEATED=129 10E3/UL. ON (B)(6) 2026 SID (B)(6): 71YRS OLD FEMALE: WBC ON ALINITY HQ 0446=6.68 AND 6.90 10E3/UL /ON ALINITY HQ 0477=2.91 10E3/UL. RBC ON ALINITY HQ 0446=4.61 AND 4.63 10E6/UL /ON ALINITY HQ 0477=2.61 10E6/UL HGB ON ALINITY HQ 0446=14.1 AND 14.1 G/DL /ON ALINITY HQ 0477 =6.93 G/DL PLATELET ON ALINITY HQ 0446=278 AND 282 10E3/UL /ON ALINITY HQ 0477= 156 10E3/UL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084950 ↗
• MalfunctionApr 29, 2026Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED HEMOGLOBIN RESULT GENERATED BY THE ALINITY HQ ANALYZER FOR A PATIENT. THE RESULT WAS NOT RELEASED OUT OF THE LABORATORY. UPON REPEAT TESTING, THE RESULT WAS HIGHER. THE FOLLOWING DATA WAS PROVIDED: NORMAL RANGE: 120 TO 155 G/L. INITIAL RESULT = 65 G/L. REPEAT RESULT (ANOTHER ANALYZER) = 103 G/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25026353 ↗
• MalfunctionApr 8, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED HEMOGLOBIN RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR A 17-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID: (B)(6) INITIAL RUN: (B)(6) 2026 07:57 PM HGB 4.84. RERUN: (B)(6) 2026 09:53 AM. HGB 10.3. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820813 ↗
• MalfunctionApr 6, 2026Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED NEUTROPHILS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR A 75-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE PROVIDED: 10E9/L): (B)(6) 2026, SID: (B)(6): (B)(6) RESULT = 0.217 AND 0.167, (B)(6) = 2.89. ADDITIONAL LABORATORY DATA WAS PROVIDED: WBC: (B)(6) RESULT = 3.82 AND 3.86, (B)(6)= 3.76, HEMOGLOBIN: (B)(6) RESULT = 88.7 G/L AND 89.7 G/L, (B)(6) = 88.5 G/L, PLATELET: (B)(6) RESULT = 121 AND 116, (B)(6) = 115, LYMPHOCYTES: (B)(6) RESULT = 0.73 AND 0.607S, (B)(6) = 0.662, MONOCYTES: (B)(6) RESULT = 2.78 AND 3.04X, (B)(6) = 0.18, EOSINOPHILS: (B)(6) RESULT = 0.043 AND 0.027, (B)(6) = 0.007, BASOPHILS: (B)(6) RESULT = 0.05 AND 0.042S, (B)(6) = 0.02. A SMEAR SLIDE WAS REVIEWED AND NO BLAST CELLS WERE SEEN. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796058 ↗
• MalfunctionApr 6, 2026High Test Results

  THE CUSTOMER OBSERVED FALSE ELEVATED PLATELET (PLT) WHEN PROCESSING ON THE ALINITY HQ PROCESSING MODULE. THE PATIENT IS A 35-YEAR-OLD FEMALE WITH ACUTE LEUKEMIA, RECENTLY UNDERGONE A TRANSPLANT. ON (B)(6) 2026, SID (B)(6) REPEATED SEVERAL TIMES GENERATED ALINITY HQ PLT OF 162, 154, 165, 179, 180, 177 10E3/UL. THE MPV VALUE AND DIFFERENTIAL WAS INVALID ON ALL RUNS. THE BLOOD SMEAR PLT ESTIMATE WAS 0-2 PLT/PMF PER FIELD EQUAL TO ABOUT 10-15,000 UL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792555 ↗
• MalfunctionFeb 11, 2026Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED HEMOGLOBIN RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR MULTIPLE PATIENTS WHEN COMPARED TO THE CUSTOMER¿S OTHER HQ MODULE (B)(6). THE FOLLOWING DATA WAS PROVIDED: TESTING WAS PERFORMED ON (B)(6) 2026: SAMPLE ID (B)(6) (77-YEAR-OLD, MALE): HEMOGLOBIN (B)(6): 6.27; REPEAT RESULT ON SAME ANALYZER: 14.5; HEMOGLOBIN RESULT (B)(6): 14.2. SAMPLE ID (B)(6) (61-YEAR-OLD, FEMALE): HEMOGLOBIN RESULT (B)(6): 6.55; HEMOGLOBIN RESULT (B)(6): 15.2. REFERENCE RANGE FOR HEMOGLOBIN: 11.50 - 16.1 G/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313927 ↗
• MalfunctionDec 22, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (HEMOGLOBIN REFERENCE RANGE: 120¿160 G/L (12.0-16.0 G/DL): SAMPLE #1: (B)(6) FIRST RUN ON TITAN (B)(6) ON (B)(6) 2025 AT 02:00, SEQ 143689: HEMOGLOBIN = 65 G/L (6.5 G/DL) NO ERROR MESSAGES ATTACHED TO THIS RUN. AN ERROR MESSAGE OCCURRED AT 02:02: 3678 0 ATMOSPHERIC WASTE FULL. BACKGROUND CHECKS AT 02:03¿02:20, SEQ 143690¿143698, ALL FAILED WITH HIGH BACKGROUND COUNTS (WBC, RBC, HEMOGLOBIN, PLT, RETIC). ERROR MESSAGE WAS GENERATED: 1836-0 CBC RETIC BACKGROUND FAILED. THE FOLLOWING TROUBLESHOOTING WAS PERFORMED: DAILY AUTO CLEAN COMPLETED AT 02:49. BACKGROUNDS PASSED AFTERWARD. DAILY DRIFT CONTROL PASSED. ANOTHER 3678-0 ATMOSPHERIC WASTE FULL ERROR OCCURRED AT 02:39. A SECOND RUN OF SAMPLE (B)(6) AT 03:20, SEQ 143710, SHOWED A NORMALIZED VALUE: HEMOGLOBIN = 149 G/L (14.9 G/DL) THIS RESULT WAS NOT TRANSMITTED TO AMS; INITIAL LOW RESULT WAS COPIED INSTEAD. SAMPLE RERUN THREE TIMES ON DAY SHIFT (09:17, 09:24, 09:32, SEQ 143735, 143747, 143748): HEMOGLOBIN RESULT OF 148¿149 G/L (14.8-14.9 G/DL) EACH TIME. AGAIN, THESE RESULTS DID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873137 ↗
• InjuryDec 18, 2025Leak/Splash; Leak/Splash

  AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS SPRAYED IN BOTH EYES WHILE FLUSHING THE WASTE LINE DURING PREVENTATIVE MAINTENANCE ON THE ALINITY HQ PROCESSING MODULE. WHILE FLUSHING THE WASTE LINES WITH BLEACH, A TUBING CONNECTION POPPED OFF, CAUSING FLUID TO SPRAY INTO BOTH EYES. THE FSR FLUSHED HIS EYES WITH WATER AND RELIWASH SALINE EYE WASH (SODIUM CHLORIDE 0.9% W/V PH.EUR) FOR 10¿15 MINUTES. HE THEN SOUGHT MEDICAL ATTENTION, WHERE HE RECEIVED ADDITIONAL SALINE IRRIGATION AND WAS PRESCRIBED AN ANTIBIOTIC EYE OINTMENT (CHLORAMPHENICOL 1.0%). SYMPTOMS INCLUDED BURNING AND BLURRED VISION, ALL OF WHICH HAVE SINCE RESOLVED. THE OINTMENT WAS DISCONTINUED ON (B)(6) 2025, AND THE FSR HAS FULLY RECOVERED. AT THE TIME OF THE INCIDENT, THE FSR WAS WEARING A LAB COAT AND GLOVES BUT WAS NOT WEARING GOGGLES. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED. UPDATE: ON 06JAN2026, THE FSR CLARIFIED THAT THE TUBING THAT POPPED OFF WAS ATTACHED TO THE SYRINGE AND NOT A PART USED FOR THE PREVENTATIVE MAINTENANCE.

  Patient problems: Blurred Vision; Burning Sensation

  MAUDE report 23836399 ↗
• MalfunctionDec 16, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED HEMOGLOBIN (HGB) RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE (SN: (B)(6) AND REPEATED ON ANOTHER ALINITY HQ PROCESSING MODULE (SN: (B)(6). THE CUSTOMER REPORTED THAT THEY ARE QUESTIONING THE FOLLOWING 3 SAMPLES FOR FALSELY LOW HEMOGLOBIN (HGB) AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SID (B)(6), INITIALLY GENERATED A HEMOGLOBIN RESULT OF 65 G/L (6.5 G/DL), AND REPEAT ANOTHER ALINITY HQ PROCESSING MODULE WAS 115 G/L (11.5 G/DL). ON (B)(6) 2025, SID (B)(6), INITIALLY GENERATED A HEMOGLOBIN RESULT OF 78.6 G/L (7.86 G/DL), AND REPEAT ANOTHER ALINITY HQ PROCESSING MODULE WAS 124 G/L (12.4 G/DL). ON (B)(6) 2025, SID (B)(6), INITIALLY GENERATED A HEMOGLOBIN RESULT OF 78.9 G/L (7.89 G/DL), AND REPEAT ANOTHER ALINITY HQ PROCESSING MODULE WAS 130 G/L (13.0 G/DL). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819249 ↗
• MalfunctionDec 11, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED HEMOGLOBIN RESULT GENERATED ON AN ALINITY HQ PROCESSING MODULE, (B)(6), WHICH REPEATED HIGHER ON ANOTHER ALINITY HQ PROCESSING MODULE, (B)(6) FOR A 48-YEAR-OLD MALE PATIENT. SID (B)(6): HGB INITIAL RESULT = 5.44L G/DL, REPEAT RESULT SID (B)(6) = 8.04L G/DL THE RESULTS GENERATED ON (B)(6) WERE NOT REPORTED OUT OF THE LAB. THERE WAS NO IMPACT TO PATIENT MANAGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779142 ↗
• MalfunctionDec 11, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED HEMOGLOBIN RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR MULTIPLE SAMPLES. THE CUSTOMER NOTED SOME INITIAL RESULTS WERE AROUND 60 G/L AND REPEATED WITHIN NORMAL RANGE ON ANOTHER INSTRUMENT. NO SPECIFIC DATA OR PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777153 ↗
• MalfunctionNov 7, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED HEMOGLOBIN ALINITY HQ RESULTS. THE RESULT WAS HIGHER WHEN REPEATED ON ANOTHER INSTRUMENT. THE FOLLOWING EXAMPLE WAS PROVIDED: ALINITY (B)(6) SID (B)(6) HEMOGLOBIN RESULT = 6.37 REPEATED ON ANOTHER INSTRUMENT = 14.6 G/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500550 ↗
• MalfunctionSep 18, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED HEMATOCRIT RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT 0.75 AND 0.7, REPEATS AT 0.4. NO INCORRECT RESULTS WERE REPORTED OUT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085925 ↗
• MalfunctionSep 15, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED NEUTROPHIL AND HEMOGLOBIN RESULTS GENERATED BY THE ALINITY HQ ANALYZER FOR TWO PATIENTS. THE RESULTS WERE RELEASED OUT OF THE LAB. THE SAMPLES WERE REPEATED YIELDING HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: PATIENT (B)(6): ON (B)(6) 2025, SID: (B)(6): HGB: INITIAL RESULT = 5.56 G/DL, REPEAT RESULT = 10.6 G/DL. PATIENT (B)(6): ON (B)(6) 2025, SID: (B)(6): NEU: INITIAL RESULT = 0.472 X 10E3/L, REPEAT RESULT = 0.942 X 10E3/L. HGB: INITIAL RESULT = 6.52 G/DL (HGB INTERFERENCE FLAG), REPEAT RESULT = 14.1 G/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051138 ↗
• MalfunctionAug 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED IMPRECISE HEMOGLOBIN (HGB) RESULTS WHEN PROCESSING ON THE ALINITY HQ PROCESSING MODULE. CUSTOMER NORMAL RANGE: 12 TO 16 G/DL SID (B)(6): HGB 8.59, REPEAT 6.72 G/DL. SID (B)(6): HGB 10.20, REPEAT 7.80 G/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881708 ↗
• MalfunctionAug 15, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED WBC RESULTS GENERATED BY THE ALINITY HQ ANALYZER FOR MULTIPLE PATIENTS. NO SYSTEM FLAGS OR ERROR MESSAGES WERE OBSERVED. THE FOLLOWING DATA WAS PROVIDED: INITIAL WBC RESULT = 0 X 10E9/L; REPEAT RESULT = 3.0 X 10E9/L, EXPECTED WBC RESULT FOR THIS PATIENT: 10 X 10E9/L, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22813754 ↗