Alinity m 08N47-095Recalls & reported problems

Abbott Molecular Inc. · Alinity m HBV AMP Kit · Class 2

Data updated Oct 13, 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 00884999047754), received between Mar 29, 2022 and Mar 29, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Readings” (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

High Readings1

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.

MalfunctionMar 29, 2022High Readings; High Readings
ABBOTT HAS RECEIVED REPORTS OF MISQUANTITATION HIGH RESULTS WHEN USING THE ALINITY M HBV AMPLIFICATION KIT. DATA ANALYSIS HAS DETERMINED THAT CARRYOVER FROM A WELL CONTAINING HIGH TITER HBV TO A NEIGHBORING WELL IS A POTENTIAL CONTRIBUTING FACTOR. CARRYOVER EVENTS MAY CAUSE NOT DETECTABLE OR LOW LEVEL QUANTITATION SAMPLES THAT ARE POSITIONED NEAR HIGH TITER POSITIVE SAMPLES IN THE ASSAY TRAY TO PRODUCE FALSELY ELEVATED (MISQUANTITATION HIGH) HBV RESULTS. A PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY M HBV ASSAY. THE POTENTIAL HAZARD ASSOCIATED WITH THIS ISSUE IS INCORRECT RESULTS (MISQUANTITATION HIGH). FIELD ACTION (FA-AM-MAR2022-269), WAS TAKEN TO ADDRESS THIS ISSUE. IT WAS DEEMED REPORTABLE PER 21CFR806 AND THEREFORE REPORTABLE UNDER 21CFR803.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13943851 ↗

Device details

UDI-DI	`00884999047754`
Brand	Alinity m
Model	08N47-095
Company	Abbott Molecular Inc.
Product code	MKT · Hepatitis Viral B DNA Detection
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 21, 2021

Device type (GMDN): Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus nucleic acid in a clinical specimen, using a nucleic acid technique (NAT). The nucleic acids detected may include genes encoding the core protein, surface antigen, e-antigen, and/or other genome regions.

Other Hepatitis Viral B DNA Detection devices

cobas® HBV 09040820190
Roche Molecular Systems, Inc. · Hepatitis Viral B DNA Detection
5 reports
COBAS® AmpliPrep / COBAS® TaqMan® HBV Test, v2.0
Roche Molecular Systems, Inc. · Hepatitis Viral B DNA Detection
1 report

All Hepatitis Viral B DNA Detection devices →

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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 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