Brand Name: VITROS Product Name: VITROS 4600 Chemistry System
Medical device recall Z-2040-2025. Published in FDA’s Enforcement Report on Jul 9, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 9, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1262 units (135 US, 1127 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
1262 units (135 US, 1127 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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:…
Every code shown here, 1,596 characters
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; April 2011 to present Total systems currently installed in the US: 135 Total systems currently installed outside the US: 1,127 Total systems installed worldwide (Product Quantity Distributed): 1,262 Note1: The catalogue number 6802445 is used to denote the VITROS 4600 Chemistry System. Catalogue number 6900440 is used to denote VITROS 4600 Chemistry System- refurbished. A VITROS 4600 Chemistry System maintains its original serial number through the refurbishment 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. Note3: The value given for “Product Quantity Distributed” is the total number of active installed systems that are in use today. This number is known to fluctuate as individual systems are installed and/or decommissioned.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution: US (Nationwide) and OUS (International) to countries of: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 9, 2025.
- FDA classified it on Jun 27, 2025.
- FDA’s Enforcement Report published it on Jul 9, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Ortho-Clinical Diagnostics, Inc., of Rochester, NY.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.