VITROS 8004707Recalls & reported problems

Ortho-Clinical Diagnostics, Inc. · VITROS Chemistry Products CHE Slides · Class 1

All models of VITROS (71)

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

Jun 10, 2025Class IIOpen, Classified
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
Z-2122-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Device details

UDI-DI	`10758750004225`
Brand	VITROS
Model	8004707
Company	Ortho-Clinical Diagnostics, Inc.
Product code	DIH · Colorimetry, cholinesterase
Class	Class 1
FDA submission	None listed
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	Jun 21, 2023

Device type (GMDN): Cholinesterase dibucaine number (percentage inhibition) IVD, reagent

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of the dibucaine number or percentage inhibition of cholinesterase activity by dibucaine in a clinical specimen.

Other Colorimetry, cholinesterase devices

VITROS 1914605
Ortho-Clinical Diagnostics, Inc. · Colorimetry, cholinesterase
1 recall0 reports

All Colorimetry, cholinesterase 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 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
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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