The Recall Desk
HighFDA (Devices)·Z-2040-2025·Announced 2025-07-09

VITROS 4600 chemistry systems may report results using expired diluent packs

VITROS 4600 Chemistry Systems are being recalled because a software anomaly can allow results to be reported using diluent packs the system treats as expired, which can produce erroneous results.

What this means for you

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: Risk-of-harm product: the manufacturer states the anomaly can result in erroneous test results, and no patient harm is reported in the source.

Plain-English summary

The VITROS 4600 Chemistry System, an in vitro diagnostic chemistry analyzer, catalog numbers 6802445 and 6900440 (refurbished), is being recalled across software versions 3.2 to 3.8.3. The action covers 1,262 units, of which 135 are installed in the United States and 1,127 outside it.

According to the manufacturer, a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled, if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint in which a CREA Urine test was processed with an RE (Reagent Expired) code even though the diluent pack was not expired and the use-expired-reagents setting was disabled. The manufacturer states this can result in erroneous test results and/or delaying test results. The FDA classified the action as Class II.

Distribution was worldwide, including nationwide in the United States and to Australia, Belgium, Bermuda, Brazil, Canada and other markets.

Laboratories should identify affected systems using the catalog numbers, UDI codes and serial number range in the recall notice and follow the instructions issued by the manufacturer.

The recalled product

Product
Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.
Manufacturer
Ortho-Clinical Diagnostics, Inc.
Category
Medical Device — Clinical chemistry analyzer
Hazard

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 (10)

  • VITROS 4600 Chemistry System
  • Product Code: 6802445
  • UDI: 10758750012343
  • VITROS 4600 Chemistry System - Refurbished
  • Product Code: 6900440
  • UDI: 10758750033201
  • Range of installed serial numbers:46000111-46001897
  • Manufacture date range: April 2011 to present Distribution date range
  • 127 Total systems installed worldwide (Product Quantity Distributed): 1
  • the system s serial numbers are sequential

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 →

Related recalls

Same manufacturer · Ortho-Clinical Diagnostics, Inc.

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Same hazard · software anomaly

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