Agency classClass IIOur severity:High FDA (Devices)·Z-1006-2025·Announced 2025-01-29

Diagnostic analyzer software may fail to alert users to expired reagents

VITROS XT 7600 Integrated System software may not warn users when Signal Reagent Packs expire, risking inaccurate or missing test results.

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: This is a Class II medical device recall with no reported illnesses or injuries. The software defect creates a risk of patient harm by potentially allowing use of expired reagents, meeting the rubric criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The VITROS XT 7600 Integrated System is an in vitro diagnostic chemistry analyzer manufactured by Ortho-Clinical Diagnostics. The device runs software version 3.8.0, which contains a defect: it may not correctly notify operators when the Signal Reagent Pack exceeds its on-board or shelf-life expiration date.

If expired reagents are used despite the missing notification, the analyzer may produce no test results or erroneous results. This could impact clinical care decisions based on inaccurate or absent laboratory data.

The recall affects 1,893 units currently installed worldwide—994 in the United States and 899 outside the U.S. Affected systems include models with catalog numbers 6844461, 6272222, and 6904003, with serial numbers from 76000001 to 76002199, manufactured from July 2018 to present.

Healthcare facilities and laboratories using affected VITROS XT 7600 systems should contact Ortho-Clinical Diagnostics for instructions on how to verify reagent expiration dates and obtain a software update.

The recalled product

Product: Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code…
Manufacturer: Ortho-Clinical Diagnostics, INc.
Category: Medical Device — In vitro diagnostic chemistry analyzer
Hazard: expired-reagent
erroneous-results
test-failure

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Ortho-Clinical Diagnostics, INc. 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, INc.

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Same hazard · expired reagent