Agency classClass IIOur severity:High FDA (Devices)·Z-2140-2014·Announced 2014-08-13

Ortho VITROS 4600 Chemistry System Recalled for Software Error

Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may associate incorrect patient demographics with sample IDs.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (incorrect patient data association) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Ortho-Clinical Diagnostics is recalling the VITROS 4600 Chemistry System due to an identified anomaly in VITROS System Software Version 3.0 and below. The recall affects 81 domestic units and 238 foreign units distributed worldwide, including the United States, Puerto Rico, and various international locations.

Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number. This error could lead to the misattribution of patient information to test results.

Healthcare facilities and users of the VITROS 4600 Chemistry System should contact Ortho-Clinical Diagnostics for instructions on how to address the software anomaly. The recall is classified as Class II by the FDA.

The recalled product

Product: VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint…
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — Laboratory Equipment
Hazard: data-integrity
mis-labeling

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 (2)

Serial Numbers J46000108 - J46000440 (J Numbers are analogous to Serial Numbers
for VITROS 4600 systems the J Numbers start with 4600XXXX)

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Ortho-Clinical Diagnostics

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Same hazard · data integrity