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ImmuLINK 0064319Recalls & reported problems

Immucor, Inc. · ImmuLINK stand-alone software is for use in a blood banking environment as an aid in interfacing and managing data between blood bank instruments, Blood Establishment Computer Software and Laboratory Information System. ImmuLINK includes the following features and/or functions: It provides the ability to create and print reports of tests and results. It supports the ability to compare current results with previous results. It supports the automatic ordering of reflex tests. It provides a tool so that test results produced by a testing platform can be remotely validated prior to delivery to an LIS. Results can also be viewed remotely and edited prior to delivery to an LIS. It provides bi-directional communication with LIS and instrument platform(s). · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888234001034), received between Mar 19, 2018 and Sep 28, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Computer Software Problem2
  • Output Problem1
  • Patient Data Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 28, 2022Computer Software Problem; Computer Software Problem

    ON (B)(6) 2022 A CUSTOMER IN NEW ZEALAND REPORTED THAT IMMULINK TRANSMITTED THE INCORRECT RESULT TO THE LIS. CUSTOMER REPORTS THAT THEY HAVE AN LIS SYSTEM THAT RECYCLES/REUSES SAMPLE IDENTIFIERS (SAMPLE CODE) FOR THE BARCODES ON THE SPECIMEN TUBES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15499780 ↗
  • MalfunctionJul 8, 2019Output Problem; Output Problem

    ON (B)(6) 2019 A CUSTOMER COMPLAINED THAT IMMULINK HAD REPORTED AN INCORRECT INTERPRETATION FOR A DONOR CONFIRM (FORWARD ABO AND RH); AN AB POSITIVE SAMPLE WAS CORRECTLY INTERPRETED ON THE NEO ANALYZER BUT THE RESULT IN IMMULINK WAS DISPLAYED A POSITIVE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8768362 ↗
  • MalfunctionMar 19, 2018Computer Software Problem; Patient Data Problem; Computer Software Problem; Patient Data Problem

    ON (B)(6) 2018, A CUSTOMER SITE REPORTED A LABEL GENERATED FROM IMMULINK SOFTWARE THAT CONTAINED THE WRONG PATIENT DEMOGRAPHIC INFORMATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7348974 ↗

Other Software, Blood Bank, Stand Alone Products devices

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Sources and updates

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