Alinity 07P7420Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380740130244), received between Jun 25, 2018 and May 24, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED LDH RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR ONE PATIENT. THE INITIAL RESULT WAS 731 U/L, REPEATED 215 AND 202 U/L (NORMAL RANGE 125 TO 220 U/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14492296 ↗
• MalfunctionNov 29, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C LACTATE DEHYDROGENASE RESULTS FOR TWO SAMPLES. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE PROVIDED: 125 TO 220), UNITS OF MEASURE = U/L): (B)(6) 2021 SID (B)(6) INITIAL RESULT = 831, REPEATS = 286 AND 222. (B)(6) 2021 SID (B)(6) INITIAL RESULT = 201, REPEATS = 171, 157, AND 156. (B)(6) 2021 SID (B)(6) INITIAL RESULT = 268, REPEATS = 326 AND 313. THE RESULTS GENERATED WERE FROM AN AUTOMATIC 1:3 DILUTION THAT WAS PROGRAMED ON THE INSTRUMENT. THE SAMPLES WERE NOT RUN UNDILUTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882019 ↗
• MalfunctionJan 29, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C LACTATE DEHYDROGENASE (LDH) RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) INITIAL LDH = 247U/L (REFERENCE RANGE 125-220U/L)/ RETEST ONE HOUR LATER = 153U/L AND 140U/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11250446 ↗
• MalfunctionDec 15, 2020High Test Results; High Test Results

  THE CUSTOMER STATED THAT A PHYSICIAN QUESTIONED FALSELY ELEVATED ALINITY C LACTATE DEHYDROGENASE ( (B)(4)) RESULTS ON ONE PATIENT. THE RESULTS OBTAINED FROM THE SAMPLES FROM THE SAME PATIENT COLLECTED ON (B)(6) 2020 WERE: SID (B)(6) 215.5 U/L, 212.1 U/L, 210.1 U/L; SID (B)(6) 243.1 U/L, 565.5 U/L, 226.0 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11010817 ↗
• MalfunctionMar 2, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY LACTATE DEHYDROGENASE (LD/LDH) RESULTS FOR A SAMPLE WERE GENERATED ON THE ALINITY C ANALYZER. THE CUSTOMER REPORTED THE SAMPLE GENERATED SID (B)(6) INITIAL RESULT OF 4154 U/L, WITH A RETEST RESULT OF 730 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8384765 ↗
• MalfunctionJun 25, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED LACTATE DEHYDROGENASE (LDH) RESULTS WHILE USING THE ALINITY C LDH ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS: ON (B)(6) 2018: INITIAL RESULT: 1023.9 U/L, RETEST 157.1 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7635270 ↗