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Alinity 08P0420Recalls & reported problems

Abbott GmbH · Alinity c Microalbumin Reagent Kit 640 Tests · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740135201), received between May 3, 2023 and May 3, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test Results” (1 report).

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

Device problems

  • Low Test Results1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 3, 2023Low Test Results; Low Test Results

    THE CUSTOMER REPORTED THAT THE MICROALBUMIN COLLEGE OF AMERICAN PATHOLOGISTS (CAP) SURVEY FAILED ON THE ALINITY C PROCESSING MODULE (B)(6), AS ALL RESULTS ON THE 5 MICROALBUMIN CAP CHALLENGE WERE FALSELY DEPRESSED AND OFF BY 1 DECIMAL PLACE. IT WAS DETERMINED THAT WHEN THE INSTRUMENT WAS FIRST INSTALLED, MG/L WAS USED FOR ALINITY C MICROALBUMIN AND AT SOME POINT IN TIME THE UNIT OF MEASURE CONFIGURATION WAS CHANGED TO MG/DL. THE CUSTOMER COMMUNICATED THAT ABBOTT ASSISTED THE CUSTOMER WITH THIS CONFIGURATION STEP. UPON FURTHER REVIEW, THE ACTUAL UNITS WERE CHANGED FOR THE ASSAY, BUT NOT FOR THE CALIBRATOR. THE CONFIGURATION VALUES WERE ALL UPDATED TO BE SYNCHRONOUS WITH THE MG/DL UNIT OF MEASURE FROM THE MG/L UNIT OF MEASURE. A DATA PULL OF ALL MICROALBUMIN SAMPLES REPORTED SINCE THE ASSAY WENT LIVE IN JANUARY 2023 WAS COMPLETED WITH A TOTAL OF 591 PATIENT SAMPLES. INITIAL REVIEW OF THE DATA DOES NOT INCLUDE DATA FROM JANUARY TO (B)(6) 2023 NOR DOES IT INCLUDE OBJECTIVE VALUES. CUSTOMER NORMAL RANGE UALB IS 0.5-29 MG/DL. THE CORRECTED RESULTS FROM THE REVIEWED DATA IS AS FOLLOWS. IN REVIEWING THE DATA: ABNORMAL TO NORMAL = 110 SPECIMENS, ABNORMAL TO ABNORMAL = 30 SPECIMENS, LESS THA

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16863273 ↗

Other TURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.