Reported Jul 9, 2025 · Ongoing
Brand Name
Ortho-Clinical Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, Inc. · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
Brand Name
5 of 5 products
| # | Product as published |
|---|---|
| 1 | VITROS |
| 2 | Product Name: VITROS XT 7600 Integrated System |
| 3 | Model/Catalog Number: (1) 6844461, (2) 6272222 |
| 4 | Software Version: version 3.2 to version 3.8.3 (all available software versions) |
| 5 | Product Description: In vitro diagnostic chemistry analyzer. |
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Barcodes Product as published — VITROS XT 7600 Integrated System 6844461— — 10758750012343UDI: 10758750012343 — VITROS XT 7600 System - Certified 6272222— — 10758750012343UDI: 10758750012343 — Range of installed serial numbers:76000109-76002327 6272222Total systems currently installed in the US: 1,019 Total systems currently installed outside the US: 939 Total systems installed worldwide (Product Quantity Distributed): 1,958 Note1: The catalogue number 6844461 is used to denote the VITROS XT 7600 Integrated System. is used to denote VITROS XT 7600 System Certified. A VITROS XT 7600 Integrated System maintains its original serial number through the certification process. Therefore, the manufacturing and distribution information for the two catalogue numbers will be combined. Note2: When manufactured, the system s serial numbers are sequential, but not all analyzers are released for distribution and therefore not installed. The range of serial numbers provided includes the identified minimum and maximum in serial numbers associated with all currently installed systems. Therefore, the amount of each system manufactured may not equal the amount of each system installed. Additionally, not all serial numbers listed are associated with an active installed analyzer in use today. - Amount recalled
- 1958 units (1019 US, 939 OUS)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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