Alinity 08P1920Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380740121839), received between Aug 2, 2021 and Mar 31, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED IMPRECISE ALINITY C MAGNESIUM RESULTS. A PATIENT SAMPLE GENERATED ALINITY C MAGNESIUM OF 6 MG/DL THAT REPEATED 1.80 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734798 ↗
• MalfunctionMar 4, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C MAGNESIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT. ON (B)(6) 2024, THE INITIAL RESULT FOR SID (B)(6) WAS 6.34 MG/DL (NORMAL REFERENCE RANGE 1.6 - 2.6 MG/DL). THE PHYSICIAN QUESTIONED THE RESULT AND NEW SAMPLE WAS DRAWN. THE RESULT OF THE SECOND SAMPLE FROM THE SAME PATIENT WAS 2.46 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832427 ↗
• MalfunctionApr 26, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED MAGNESIUM RESULT GENERATED ON THE ALINITY C ANALYZER ON A PATIENT. RESULTS PROVIDED: (B)(6) 2022, SID (B)(6) = 1.9 / 1.1 / 1.8 MG/DL (NORMAL RANGE: 1.6-2.6 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14208161 ↗
• MalfunctionJan 6, 2022High Test Results; High Test Results

  THE CUSTOMER QUESTIONED ALINITY C MAGNESIUM RESULTS FOR ONE PATIENT. THE CUSTOMER USES THE REFERENCE RANGE 0.66 TO 1.07 MMOL/L. THE FOLLOWING INFORMATION WAS PROVIDED: SID: (B)(6), AGE: (B)(6), PATHOLOGY: HEMATOLOGY DEPARTMENT. ON (B)(6) 2021 RESULT 2.46 MMOL/L, REPEATED 0.82 MMOL/L AND 0.83 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13178673 ↗
• MalfunctionDec 20, 2021High Test Results; High Test Results

  THE CUSTOMER GENERATED FALSE ELEVATED MAGNESIUM RESULT FOR SID (B)(6) OF 6.1 MG/DL ON A PATIENT THAT REPEATED AS 1.9 MG/DL WHEN PROCESSING ON THE ALINITY C PROCESSING MODULE. THE ACCOUNT USES A MAGNESIUM REFERENCE RANGE OF 1.6 TO 2.6 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13049585 ↗
• MalfunctionDec 9, 2021High Test Results; High Test Results

  THE CUSTOMER STATED THAT FALSELY ELEVATED MAGNESIUM RESULTS WERE GENERATED ON THE ALINITY C PROCESSING MODULE. ONE EXAMPLE WAS PROVIDED. SAMPLE ID (B)(6) TESTED AT 0.66, 0.39 AND 0.66 MMOL/L ON NOVEMBER 16, 2021 USING REAGENT LOT 28011UD00. THE CUSTOMER'S CRITICAL RANGE IS BELOW 0.4 MMOL/L. THE SAMPLE WAS TESTED TWO ADDITIONAL TIMES WITH RESULTS OF 0.39 AND 0.41 MMOL/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THIS INCIDENT IS DEEMED REPORTABLE PER CRITERIA LISTED IN Q-22-01-015, EDITION 004 REGARDING DISCREPANT TEST RESULTS FOR MAGNESIUM. WHEN THE INITIAL RESULT IS WITHIN THE NORMAL RANGE OR HIGHER AND THE REPEAT RESULT WAS LESS THAN OR EQUAL TO 0.53 MMOL/L, THE EVENT IS REPORTABLE. ADDITIONAL DATA WAS PROVIDED BY THE CUSTOMER AND ATTACHED TO CROSS-REFERENCED TICKET (B)(4) ON DECEMBER 15, 2021. FOR THE ANALYZER DOCUMENTED IN THIS TICKET, AN ADDITIONAL DISCREPANT RESULT (SAMPLE ID (B)(6)) WAS DOCUMENTED IN THE ATTACHMENT. THE CUSTOMER USED A DIFFERENT ALINITY C MAGNESIUM REAGENT LOT (27374UD00) ON (B)(6) 2021 FOR THAT SAMPLE. A FALSELY ELEVATED RESULT OF 1.06 MMOL/L RETESTED AT 0.49 MMOL/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THIS SAMPLE IS ALSO DEEME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12969076 ↗
• MalfunctionSep 21, 2021High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ALINITY C MAGNESIUM RESULT OF 5.49 MG/DL WAS GENERATED FOR A PATIENT SAMPLE (ID(B)(6)) ON (B)(6) 2021. THE SAMPLE RETESTED AT 1.22, 1.17 AND 1.68 MG/DL. THE SAME SAMPLE WAS RETESTED ON (B)(6) 2021 ((B)(6)) AND THE RESULTS WERE 3.76, 1.28, 2.32, 1.05 AND 1.08 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509809 ↗
• MalfunctionAug 31, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY C MAGNESIUM RESULT FOR ONE SAMPLE GENERATED ON INSTRUMENT SERIAL NUMBER (B)(4). THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 0.74 MMOL/L, REPEAT ON THE SAME INSTRUMENT = 0.5 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12390831 ↗
• MalfunctionAug 2, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS ON ALINITY C PROCESSING MODULE FOR ONE MALE PATIENT. THE RESULTS PROVIDED WERE: (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258613 ↗