Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (
Pending LLM rewrite. Source: FDA_DEVICE Z-2040-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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. This can result in erroneous test results and/or delaying test results.
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 — Devices
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.
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