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 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
Why it was recalled
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.
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
Product Code: 6802783, UDI-DI: 10758750002979; Product Code: 6802914, UDI-DI: 10758750007103; Serial Numbers: J36000109 J36000294 J36001012 J36001489 J36000292 J36000340 J36001024 J36001495 J36000484 J36000348 J36001027 J36001513 J36000489 J36000446 J36001051 J36001515 J36000955 J36000511 J36001088 J36001519 J36001151 J36000517 J36001108 J36001528 J36001167 J36000580 J36001111 J36001535 J36001222 J36000688 J36001112 J36001570 J36001283 J36000753 J36001117 J36001573 J36001330 J36000861 J36001237 J36001575 J36001348 J36000877 J36001245 J36001579 J36000920 J36001246 J36001581 J36000923 J36001401 J36001582 J36000929 J36001403 J36001583 J36000933 J36001427 J36001600 J36000941 J36001451 J36001602 J36000942 J36001488 J36001618 J36001000
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
US Nationwide. Global Distribution.
Recall record
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Product type
- Devices
- Recall number
- Z-0543-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Rochester, NY
- Recall initiated
- 2023-10-10
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-0543-2024 · Source: openFDA enforcement.