Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2367-2020·Announced 2020-06-24

Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Performance Verifier II

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Performance Verifier II units because multiple coatings of AMYL Slides show imprecision on control fluids.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a performance issue (imprecision) without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317. This product is used for in vitro diagnostic purposes to quantitatively measure amylase activity in serum, plasma, and urine using specific VITROS Chemistry Systems and Integrated Systems.

The recall is being issued because multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab standard deviation (SD) as listed on the Performance Verifier (PV) Assay Sheets. The affected units are associated with Current Control Assay Sheet SD 10.5 and 10.8, and Revised Control Assay Sheet 17.1 and 17.6.

The product was distributed worldwide, including nationwide in the United States across numerous states. Users of the affected product should contact Ortho-Clinical Diagnostics for further instructions on how to proceed.

The recalled product

Product: VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and…
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — In Vitro Diagnostics
Hazard: imprecision
performance-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Current Control Assay Sheet SD 10.5
10.8 Revised Control Assay Sheet 17.1
17.6

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Ortho-Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Ortho-Clinical Diagnostics

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Same hazard · imprecision