Albumin BCP 5975573190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630928064), received between Mar 13, 2023 and Mar 13, 2023 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K844426); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionMar 13, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ALBP ALBUMIN BCP ON A COBAS 8000 C702 MODULE (SERIAL NUMBER (B)(4). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN ALBUMIN VALUE OF 82.9 G/L AND IT REPEATED AS 40.0 G/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16531768 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K844426. One submission often covers many models, so check the product and lot details in each record.

• Z-1194-2019 · Mar 18, 2019 · Terminated
  Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.