Alinity 07P5730Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00380740135409), received between Dec 17, 2018 and Feb 20, 2026 — classified as 51 malfunctions.

The most frequently reported specific device problem is “High Test Results” (42 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CALCIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE FOR A 60-YEAR-OLD MALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED FOR ONE SAMPLE (CUSTOMER¿S REFERENCE RANGE 2.15-2.51 MMOL/L): SAMPLE ID (B)(6): (B)(6) 2026 INITIAL RESULT = 3.87 MMOL/L (B)(6) 2026 NEW SAMPLE OBTAINED. SAMPLE ID (B)(6) RESULT = 2.42 MMOL/L, IONIZED CALCIUM RESULT = 1.27 MMOL/L (NORMAL RANGE 1.15-1.29 MMOL/L) (B)(6) 2026 NEW SAMPLE OBTAINED AND RESULT WITH DIFFERENT LOT = 2.39 MMOL/L . THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EVALUATION, HOWEVER, NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400211 ↗
• MalfunctionDec 1, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS GENERATED FROM ALINITY C PROCESSING MODULE FOR A 5-MONTH-OLD FEMALE PATIENT. RESULTS WERE REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. ON (B)(6) 2025, SID: (B)(6), INITIAL RESULT ON THIS ANALYZER = 3.86 MMOL/L, REPEAT RESULTS =3.10 MMOL/L. ON (B)(6) 2025, SID: (B)(6); (B)(6), RESULTS WERE 3.17 MMOL/L & 3.26 MMOL/L WITH CNTL FLAG, AND REPEAT RESULTS WERE 2.35 MMOL/L & 2.34 MMOL/L. ON (B)(6) 2025, SID: (B)(6); (B)(6), RESULTS WERE 2.16 MMOL/L & 2.14 MMOL/L, ON (B)(6) 2025, SID: (B)(6); (B)(6), RESULTS WERE 3.86 MMOL/L, 3.01 MMOL/L, 2.14 MMOL/L, 2.16 MMOL/L, ON (B)(6) 2025, SID: (B)(6); (B)(6), RESULTS WERE 2.05 MMOL/L, 2.05 MMOL/L. THE CUSTOMER USES REFERENCE RANGE FOR NORMAL: 2.1 - 2.55 MMOL/L& ABNORMAL 1.5 - 3.0 MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687652 ↗
• MalfunctionJul 10, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED DISCREPANT CALCIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON TWO PATIENTS THAT WERE NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025, SID (B)(6), SN# (B)(6) = 1.89 / 2.1, SN# (B)(6) = 4.29 (LOT# 77018UN24). ON (B)(6) 2025, SID (B)(6), SN# (B)(6) = 2.6, SN# (B)(6) = 3.83 (LOT# 53701UN24). CUSTOMER REFERENCE RANGE TOTAL CALCIUM 2.20 - 2.60 MMOL/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22466790 ↗
• MalfunctionJun 4, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED DISCREPANT CALCIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025, SID (B)(6), SN# (B)(6) = 1.89 / 2.1, SN# (B)(6) = 4.29. ON (B)(6) 2025, SID (B)(6), SN# (B)(6) = 2.6, SN# (B)(6) = 3.83. CUSTOMER REFERENCE RANGE TOTAL CALCIUM 2.20 - 2.60 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22139627 ↗
• MalfunctionApr 24, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM GENERATED FROM ALINITY C PROCESSING MODULE. THE CUSTOMER COMPARED RESULTS WITH OTHER ANALYZERS, INCLUDING THE ARCHITECT PLATFORM AND PROVIDED THE FOLLOWING DATA: CUSTOMER REFERENCE RANGE FOR ADJUSTED CALCIUM IS 2.2-2.6MMOL/L. CUSTOMER REFERENCE RANGE FOR CALCIUM IS 1.75-3MMOL/L. SAMPLE ID (B)(6). RESULTS ON ALINITY WERE 3.04 (ON SN: (B)(6), 4.78 (ON SN:(B)(6), & 4.30 MMOL/L (ON SN: (B)(6). RESULT ON ARCHITECT WERE 2.12 & 2.49 MMOL/L. 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 21906149 ↗
• MalfunctionMar 22, 2025High Test Results; High Test Results

  THE CUSTOMER GENERATED FALSE ELEVATED ALINITY C CALCIUM RESULT ON A SAMPLE THAT REPEATED LOWER. ON 10MAR2025, (B)(6) GENERATED ELEVATED ALINITY C CALCIUM OF 4.53 AND 4.41 MMOL/L. THE SAMPLE WAS PROCESSED AGAIN SEVERAL TIMES USING ALINITY AND ARCHITECT ANALYZERS WITH VALUES RANGING FROM 2.02 TO 2.21 MMOL/L. THE SAMPLE HAD GROSS HAEMOLYSIS. THE CUSTOMER USES A CALCIUM REFERENCE RANGE OF 2.2 TO 2.6 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21671559 ↗
• MalfunctionMar 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C CALCIUM RESULTS FOR MULTIPLE SAMPLES. THE FOLLOWING EXAMPLE DATA WAS PROVIDED: (B)(6) 2025, SID (B)(6): INITIAL RESULT ON AC05254 = 4.21 MMOL/L, REPEAT = 2.80 MMOL/L, REPEAT ON AC06069 =2.29 MMOL/L. THE CUSTOMER INDICATED THAT THE PATIENT HAD TO BE DRAWN. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21587529 ↗
• MalfunctionMar 5, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C CALCIUM RESULTS FOR ONE SAMPLE GENERATED ACROSS MULTIPLE ALINITY I PROCESSING MODULES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE: 8.4-10.2 MG/DL): ON (B)(6) 2025, SID (B)(6): INITIAL RESULT = 14.00 MG/DL (RAN ON (B)(6), REPEAT RESULTS = 16.20 / 16.60 / 18.50 MG/DL (ALL RAN ON (B)(6), RETEST ON (B)(6) = 8.60 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21531383 ↗
• MalfunctionFeb 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED IMPRECISE ALINITY C CALCIUM RESULTS GENERATED BY THE ALINITY C PROCESSING MODULE FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S ADJUSTED CALCIUM RANGE: 2.20 TO 2.60 MMOL/L. SID: (B)(6): ON (B)(6) 2025 INITIAL RESULT = 1.1 MMOL/L (B)(6). REPEAT RESULTS = 1.1 MMOL/L (B)(6), 2.3 MMOL/L (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21490461 ↗
• MalfunctionFeb 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED IMPRECISE ALINITY C CALCIUM RESULTS GENERATED BY THE ALINITY C PROCESSING MODULES FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S ADJUSTED CALCIUM RANGE: 2.20 TO 2.60 MMOL/L. SID: (B)(6): ON (B)(6) 2024 INITIAL RESULT = 0.83 MMOL/L (AC01433 WITH REAGENT LOT#: 25020UN24). REPEAT RESULTS = 0.9 MMOL/L (AC01433), 2.38 MMOL/L (AC01250 WITH REAGENT LOT#: 25020UN24). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21489880 ↗
• MalfunctionFeb 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED IMPRECISE ALINITY C CALCIUM RESULTS GENERATED BY THE ALINITY C PROCESSING MODULES FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S ADJUSTED CALCIUM RANGE: 2.20 TO 2.60 MMOL/L. SID (B)(6): ON (B)(6) 2023 INITIAL RESULT = 1.26 MMOL/L (B)(6) WITH UNKNOWN REAGENT LOT#). REPEAT RESULT = 2.34 MMOL/L (B)(6) WITH UNKNOWN REAGENT LOT#). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21489797 ↗
• MalfunctionFeb 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED IMPRECISE ALINITY C CALCIUM RESULT GENERATED BY THE ALINITY C PROCESSING MODULE FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S ADJUSTED CALCIUM RANGE: 2.20 TO 2.60 MMOL/L. SID (B)(6): ON (B)(6) 2023 INITIAL RESULT = 0.78 MMOL/L (B)(6), REPEAT RESULTS = 0.77 MMOL/L, 2.42 MMOL/L (B)(6) , THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21478463 ↗
• MalfunctionFeb 24, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C CALCIUM (CA) RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT SAMPLE. THE FOLLOW DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE FOR CALCIUM: 8.4-10.2 MG/DL): SID (B)(6): INITIAL CA RESULT = 14.9 MG/DL; REPEAT ON ANOTHER ANALYZER (B)(6) = 12.5 MG/DL; REPEATED ON A THIRD ANALYZER = 8.9 MG/DL. THE SAMPLE WAS PROCESSED WITH THE CALCIUM 2 REAGENT AND GENERATED RESULTS OF 8.7 AND 8.9 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21453047 ↗
• MalfunctionFeb 20, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CALCIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE ON A PATIENT. RESULTS PROVIDED: (B)(6). SN# (B)(6) = 9.52 / 13.62 MG / DL WITH REAGENT 88813UN24, SN# (B)(6) = 16.15 WITH REAGENT 66462UN24, SN# (B)(6) = 17.09 / 11.9 WITH REAGENT 88813UN24, REFERENCE RANGE: 8.4 TO 10.2 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420263 ↗
• MalfunctionFeb 20, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CALCIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE ON A PATIENT. RESULTS PROVIDED:(B)(6). SN# (B)(6) = 9.52 / 13.62 MG / DL WITH REAGENT 88813UN24. SN# (B)(6) = 16.15 WITH REAGENT 66462UN24. SN# (B)(6) = 17.09 / 11.9 WITH REAGENT 88813UN24. REFERENCE RANGE: 8.4 TO 10.2 MG/DL . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420262 ↗
• MalfunctionFeb 10, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED DISCREPANT CALCIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025, SID (B)(6) = 3.21 / 3.51 / 3.18 / 2.53 MMOL/L. (B)(6) = 3.3 / 3.72 / 4.19 / 2.503 / 2.499 / 2.515 MMOL/L. REFERENCE RANGE: 2.2 ¿ 2.6 MMOL/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343093 ↗
• MalfunctionJan 27, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY C CALCIUM RESULTS FOR MULTIPLE SAMPLES. THE FOLLOWING EXAMPLE DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 2.20 TO 2.60 MMOL/L): ON (B)(6) 2025, SID (B)(6): INITIAL RESULT ON (B)(6) INITIAL RESULT = 4.27 MMOL/L, REPEAT ON (B)(6) = 3.51 MMOL/L, REPEAT ON (B)(6) = 4.43 MMOL/L, REPEAT ON (B)(6) = 2.34 MMOL/L. ADDITIONAL LABORATORY DATA PROVIDED: POTASSIUM = 7.0, H INDEX = 0.14, ICTERIC INDEX = 14.50, LIPEMIA INDEX = 0.26. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241528 ↗
• MalfunctionNov 27, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS GENERATED ACROSS TWO ALINITY C PROCESSING MODULES FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), PROCESSED ON (B)(6) 2024 ON (B)(6) = 3.40 MMOL/L, 3.52 MMOL/L, 3.13 MMOL/L, AND 2.08 MMOL/L (LOT 45184UN24), (B)(6) = 3.25 MMOL/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795271 ↗
• MalfunctionNov 27, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C CALCIUM RESULTS FOR MULTIPLE SAMPLES. THE RESULTS ARE IMPRECISE ACROSS MULTIPLE ALINITY C PROCESSING MODULES. THE CUSTOMER PROVIDED THE FOLLOWING DATA (CUSTOMER PROVIDED REFERENCE RANGE IS 2.2 TO 2.6 MMOL/L): SID (B)(6), PROCESSED ON (B)(6)2024 ON (B)(6) = 3.82 MMOL/L (LOT 88813UN24), (B)(6) = 3.34 (LOT 88813UN24), (B)(6) WAS >6.00 MMOL/L (LOT 88813UN24), (B)(6) = 2.46 MMOL/L (LOT 88813UN24). SID (B)(6), PROCESSED ON (B)(6) 2024 ON (B)(6) RESULTS = 3.07 MMOL/L AND 4.20 MMOL/L, (B)(6) = 2.35 MMOL/L, (B)(6) = 2.41 MMOL/L. SID (B)(6), PROCESSED ON (B)(6)2024 ON (B)(6) RESULTS = 3.49 MMOL/L (LOT 17995UN23), (B)(6) = 4.05 MMOL/L (LOT 04893UN24), (B)(6) = 2.23 MMOL/L, AND 2.34 MMOL/L (LOT 88813UN24), (B)(6) = 2.16 MMOL/L .(88813UN24) SID (B)(6), PROCESSED ON (B)(6)2024 ON (B)(6) = 3.66 MMOL/L AND 2.20 MMOL/L (LOT 04893UN24). SID (B)(6), PROCESSED ON (B)(6)2024 ON (B)(6) = 2.38 MMOL/L AND 3.86 MMOL/L (LOT 04893UN24). SID (B)(6), PROCESSED ON (B)(6)2024 ON (B)(6) = 2.60 MMOL/L (LOT 88813UN24), (B)(6) = 3.29 MMOL/L (LOT 88813UN24), (B)(6)= 4.08 MMOL/L, 3.98 MMOL/L, 2.26 MMOL/L, AND 2.25 MMOL/L (LOT 88813UN24). NO IMPACT TO PATIENT MANAGEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795168 ↗
• MalfunctionOct 29, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS GENERATED ON THE ALINITY C ANALYZER. THE RESULTS WERE NOT REPORTED OUT. THE RESULTS ARE IMPRECISE ACROSS MULTIPLE ALINITY C PROCESSING MODULES FOR 3 PATIENTS. THE CUSTOMER PROVIDED THE FOLLOWING DATA: SID (B)(6). PROCESSED ON (B)(6) 2024 ON ALINITY SERIAL NUMBER (B)(6) CALCIUM = 4.79 REPEATED ON (B)(6) = 4.26 REPEATED ON (B)(6) 2024 ON (B)(6) = 2.43 AND 2.63 REPEATED ON (B)(6) = 1.93 MMOL/L SID (B)(6) PROCESSED ON (B)(6) 2024 ON (B)(6) = >6.0 REPEATED ON (B)(6) = 2.19 ANOTHER REPEAT ON AL5 = 4.81 MMOL/L SID (B)(6) PROCESSED ON (B)(6) 2024 INITIAL RESULT ON ALINITY (B)(6) = 3.07 REPEAT RESULT = 4.20 REPEATED ON (B)(6) 2024 ON (B)(6) RESULT = 2.35 REPEATED ON (B)(6) = 2.41. REFERENCE RANGE = 2.2-2.6 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. ADDITIONAL DATA WAS PROVIDED BY THE CUSTOMER: SID (B)(6) PROCESSED ON (B)(6) 2024 ON (B)(6) = 3.82 MMOL/L (LOT 88813UN24), (B)(6) = 3.34 (LOT 88813UN24), (B)(6) WAS >6.00 MMOL/L (LOT 88813UN24), (B)(6) = 2.46 MMOL/L (LOT 88813UN24). SID (B)(6) PROCESSED ON (B)(6) 2024 ON (B)(6) RESULTS = 3.07 MMOL/L AND 4.20 MMOL/L, (B)(6) = 2.35 MMOL/L, AC05253 = 2.41 MMOL/L. SID (B)(6) PROCESSED ON (B)(6

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559626 ↗
• MalfunctionOct 29, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS GENERATED ON THE ALINITY C ANALYZER. THE RESULTS WERE NOT REPORTED OUT. THE RESULTS ARE IMPRECISE ACROSS MULTIPLE ALINITY C PROCESSING MODULES FOR 3 PATIENTS. THE CUSTOMER PROVIDED THE FOLLOWING DATA: SID (B)(6), PROCESSED ON (B)(6)2024 ON ALINITY SERIAL NUMBER (B)(6) CALCIUM = 4.79 REPEATED ON (B)(6) = 4.26 REPEATED ON (B)(6)2024 ON (B)(6) = 2.43 AND 2.63 REPEATED ON (B)(6) = 1.93 MMOL/L. SID (B)(6), PROCESSED ON (B)(6)2024 ON (B)(6) = >6.0 REPEATED ON (B)(6) = 2.19 ANOTHER REPEAT ON AL5 = 4.81 MMOL/L. SID (B)(6), PROCESSED ON (B)(6) 2024 INITIAL RESULT ON ALINITY (B)(6) = 3.07 REPEAT RESULT = 4.20 REPEATED ON (B)(6) 2024 ON (B)(6) RESULT = 2.35 REPEATED ON (B)(6) = 2.41. REFERENCE RANGE = 2.2-2.6 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. ADDITIONAL DATA WAS PROVIDED BY THE CUSTOMER: SID (B)(6), PROCESSED ON (B)(6) 2024 ON (B)(6) = 3.82 MMOL/L (LOT 88813UN24), (B)(6) = 3.34 (LOT 88813UN24), (B)(6) WAS >6.00 MMOL/L (LOT 88813UN24), (B)(6) = 2.46 MMOL/L (LOT 88813UN24). SID (B)(6), PROCESSED ON (B)(6)2024 ON (B)(6) RESULTS = 3.07 MMOL/L AND 4.20 MMOL/L, (B)(6) = 2.35 MMOL/L, (B)(6) = 2.41 MMOL/L. SID (B)(6), PROCESSED ON (B)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559427 ↗
• MalfunctionOct 22, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CALCIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 SID (B)(6) = ALINITY (B)(6) = 14.61 / 13.85, ANOTHER ALINITY (B)(6) = 13.7 MG/DL. (B)(6) 2024 (B)(6) = 13.80 / 10.20 MG/DL; (B)(6) = 10.89 MG/DL; (B)(6) = 11.12 MG/DL, REPEATED ON (B)(6) 2024 (B)(6) = 10.15 / 10.16 MG/DL; NEW SAMPLE PROCESSED ON (B)(6) = 13.8 / 10.2 MG/DL (B)(6) 2024 (B)(6) = 9.27 / 9.25 MG/DL; (B)(6) = 9.37 / 9.40 MG/DL; (B)(6) = 9.24 / 9.22 MG/DL; (B)(6) = 9.25 / 9.31 MG/DL. (B)(6) 2024 SID (B)(6) = AC07086 = 14.73 MG/DL, (B)(6) = 15.06 MG/DL; REPEATED SAMPLE ON (B)(6) 2024 (B)(6) = 9.06 / 9.17 MG/DL. (B)(6) 2024 (B)(6) = 8.53 / 8.56 MG/DL; (B)(6) = 8.59 / 8.67 MG/DL; (B)(6) = 8.43 / 8.47 MG/DL; (B)(6) = 8.57 / 8.45 MG/DL. CUSTOMER¿S NORMAL RANGE: 8.4-10.2 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504242 ↗
• MalfunctionOct 22, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CALCIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2024, SID: (B)(6) = ALINITY AC07087 = 14.61 / 13.85, ANOTHER ALINITY (AC07088) = 13.7 MG/DL. ON (B)(6) 2024, AC07090 = 13.80 / 10.20 MG/DL; AC07084 = 10.89 MG/DL; AC07085 = 11.12 MG/DL, REPEATED. ON (B)(6) 2024 AC07087 = 10.15 / 10.16 MG/DL; NEW SAMPLE PROCESSED ON AC07091 = 13.8 / 10.2 MG/DL. ON (B)(6) 2024, AC07090 = 9.27 / 9.25 MG/DL; AC07091 = 9.37 / 9.40 MG/DL; AC07086 = 9.24 / 9.22 MG/DL; AC07087 = 9.25 / 9.31 MG/DL. ON (B)(6) 2024, SID: (B)(6) = AC07086 = 14.73 MG/DL, AC07087 = 15.06 MG/DL; REPEATED SAMPLE ON (B)(6) 2024, AC07091 = 9.06 / 9.17 MG/DL. ON (B)(6) 2024, AC07090 = 8.53 / 8.56 MG/DL; AC07091 = 8.59 / 8.67 MG/DL; AC07086 = 8.43 / 8.47 MG/DL; AC07087 = 8.57 / 8.45 MG/DL. CUSTOMER¿S NORMAL RANGE: 8.4-10.2 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504233 ↗
• MalfunctionAug 30, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CALCIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 8.4-10.2 MG/DL): 20AUG2024 SAMPLE ID (B)(6) INITIAL RESULT GENERATED ON ANALYZER AC07086= 11.21 MG/DL, 21AUG2024 REPEAT RESULT ON SAME ANALYZER = 8.59 MG/DL 21AUG2024 SAME SAMPLE REPEATED ON ANALYZER AC07085 AND RESULTS = 15.78 MG/DL, 15.37 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20106598 ↗
• MalfunctionJul 10, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C CALCIUM FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 2.10 TO 2.55 MMOL/L): ON (B)(6) 2024, SID (B)(6) INITIAL RESULT= 4.072 MMOL/L; REPEAT RESULT= 2.54 MMOL/L . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710625 ↗