Alere NMP22 BladderChek Test D1200Recalls & reported problems

Alere Scarborough, Inc. · The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer. · Class 3

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10811877010569), received between Nov 9, 2021 and Nov 9, 2021 — classified as 1 injury.

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

Most reported problems

Device problems

Use of Device Problem1

Patient problems

Visual Impairment1

Recent adverse event reports

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

InjuryNov 9, 2021Use of Device Problem; Use of Device Problem
THE HOSPITAL REPORTED THAT THERE WERE AFFECTED KIT BOXES THAT HAD DAMAGED DESICCANT POUCHES. THE DESICCANT SCATTERED WHEN UNPACKING THE REAGENT BOARD AND THE PACKAGING BAG SPLASHED INTO THE EYES OF THE OPERATOR. THEY WENT TO THE OPHTHALMOLOGY DEPARTMENT FOR MEDICAL TREATMENT WITHOUT MAJOR PROBLEMS. NO OTHER SERIOUS INJURIES.
Patient problems: Visual Impairment
MAUDE report 12783652 ↗

Device details

UDI-DI	`10811877010569`
Brand	Alere NMP22 BladderChek Test
Model	D1200
Company	Alere Scarborough, Inc.
Product code	NAH · System, Test, Tumor Marker, For Detection Of Bladder Cancer
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jun 28, 2024

Device type (GMDN): Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of nuclear matrix protein 22 (NMP22) [also known as nuclear mitotic apparatus protein 1] in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses typically to aid in the diagnosis of urological conditions (e.g., bladder cancer, prostate cancer). It is not intended to be used for self-testing.

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.

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