Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Why it was recalled
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
VITROS System Software Version 3.8.1 Regular UDI-DI 10758750002740 Refurbished UD-DI 10758750007110 Serial Numbers US: J56001885 J56003484 J56001886 J56003541 J56001910 J56003570 J56002308 J56003583 J56002461 J56003646 J56002474 J56003669 J56002608 J56003670 J56002698 J56004068 J56002704 J56004137 J56003342 J56004174 J56003356 J56004491 J56003377 J56004506 J56003433 J56004549 J56003477 J56004551 J56003478 J56004577 OUS: J56000425 J56002518 J56000512 J56002615 J56000533 J56002625 J56000674 J56002637 J56000680 J56002926 J56000719 J56002929 J56000809 J56003061 J56000831 J56003260 J56000836 J56003285 J56001051 J56003401 J56001111 J56003464 J56001114 J56003508 J56001208 J56003523 J56001731 J56003538 J56001765 J56004346 J56001826 J56004355 J56001853 J56004415 J56002085 J56004531 J56002116 J56004695
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.
Recall record
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Product type
- Devices
- Recall number
- Z-1226-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Rochester, NY
- Recall initiated
- 2024-01-26
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1226-2024 · Source: openFDA enforcement.