NeoBase 2 Non-derivatized MSMS kit 3044-001URecalls & reported problems

Wallac Oy · NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations from newborn heel prick blood samples dried on filter paper. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 06438147356812), received between Apr 29, 2025 and Apr 29, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1
Insufficient Device Problem Information1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionApr 29, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
FOLLOW-UP REPORT. ON 07-MAY-2025 MANUFACTURER RECEIVED INFORMATION THAT THE CUTOFF FOR C26:0-LPC HAS BEEN CHANGED FROM GREATER THAN EQUAL TO 0.49 MOL/L TO GREATER THAN EQUAL TO 0.47 MOL/L ON (B)(6) 2024. THEREFORE, IN THE FIRST RETEST THE MEASURED C26:0-LPC CONCENTRATION 0.47 MOL/L WAS AT CUTOFF, NOT BELOW AS STATED IN THE INITIAL REPORT.
Patient problems: Insufficient Information
MAUDE report 21928682 ↗

Device details

UDI-DI	`06438147356812`
Brand	NeoBase 2 Non-derivatized MSMS kit
Model	3044-001U
Company	Wallac Oy
Product code	NQL · System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Class	Class 2
FDA submission	K173568, K193103
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 15, 2022

Device type (GMDN): Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple amino acids, nucleosides, lysophospholipids, and/or carnitine metabolites associated with metabolic disorders of a newborn in a clinical specimen, using a mass spectrometry method. Analytes detected may include all amino acids, free carnitine, acylcarnitine, succinylacetone, adenosine and/or lysophosphatidylcholine.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page