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Specimen Gate Laboratory 5002-0180Recalls & reported problems

Wallac Oy · Specimen Gate® Laboratory is a modular laboratory information management system intended for use as a calculator/data processing software for the storage, retrieval, and processing of laboratory data in newborn screening laboratories. · 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 06438147153312), received between Feb 9, 2021 and Feb 9, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (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

  • Computer Software Problem1
  • False Negative Result1
  • Incorrect, Inadequate or Imprecise Result or Readings1
  • Output Problem1

Patient problems

  • Congenital Defect/Deformity1

Recent adverse event reports

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

  • MalfunctionFeb 9, 2021Computer Software Problem; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Computer Software Problem; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

    ON (B)(6) 2020 PERKINELMER WAS NOTIFIED OF AN ISSUE WITH NEWBORN SCREENING RESULTS REPORTING. THE CUSTOMER REPORTED THAT A (B)(6) WAS DIAGNOSED WITH SICKLE CELL DISEASE, BUT AT THE TIME OF NEWBORN SCREENING THE PATIENT'S REPORT REFLECTED A NORMAL RESULT. REVIEW OF THE CHILD´S NEWBORN SCREENING RECORDS SHOWED THAT THE INITIAL RESULT WAS ABNORMAL. THE CONFIRMATORY TEST WAS ALSO ABNORMAL. AFTER THE CONFIRMATORY RESULTS WERE AVAILABLE, THE USER MANUALLY ENTERED THE ABNORMAL RESULT INTO SPECIMEN GATE LABORATORY. AN INVESTIGATION REVEALED THAT THE ABNORMAL RESULT PROVIDED BY THE USER HAD NOT BEEN RECORDED IN ALL EXPECTED FIELDS IN SPECIMEN GATE LABORATORY RESULTING IN AN INCORRECTLY REPORTED SCREENING RESULT. SIXTEEN SPECIMENS WERE AFFECTED BY THE ERROR. TWO SPECIMENS HAD NORMAL RESULTS AND WERE PROCESSED CORRECTLY. FOURTEEN SPECIMENS HAD ABNORMAL RESULTS AND WERE REPORTED INCORRECTLY AS NORMAL. THE FOURTEEN INCLUDES THE SPECIMEN OF THE (B)(6) PATIENT DISCUSSED ABOVE PLUS THIRTEEN SPECIMENS. THE ABNORMALITIES SHOULD HAVE BEEN REPORTED WITH A RECOMMENDATION TO OBTAIN DIAGNOSTIC TESTING, AND ARE RECOMMENDED TO HAVE CONSULTATION AND FURTHER CLINICAL FOLLOW UP. THE REPORTED HGB RESULTS, INCL

    Patient problems: Congenital Defect/Deformity

    MAUDE report 11302026 ↗

Other Calculator/Data Processing Module, For Clinical Use devices

All Calculator/Data Processing Module, For Clinical Use devices →

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