CLASS II ONGOING Device recall · Reported 13 Mar 2024 · FDA Enforcement Report
Vitros 3600 Immunodiagnostic System recalled
Ortho-Clinical Diagnostics is recalling Vitros 3600 Immunodiagnostic System, distributed nationwide in the US. The recall was initiated on 26 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1224-2024
- FDA event ID
- 93925
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jan 2024
- FDA classified
- 1 Mar 2024
- Reported
- 13 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Jan 2024 | Recall initiated by company | |
| 1 Mar 2024 | Classified by FDA | +35 days |
| 13 Mar 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
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.
Nationwide ArizonaCaliforniaConnecticutFloridaIowaIdahoIllinoisIndianaKentuckyLouisianaMissouriNebraskaNew YorkOhioOregonSouth CarolinaSouth DakotaTexasWashingtonWisconsin
Questions about this recall
Is Vitros 3600 Immunodiagnostic System recalled?
Yes. Ortho-Clinical Diagnostics recalled Vitros 3600 Immunodiagnostic System on 26 Jan 2024. The recall is Class II and its status is Ongoing. Recall number Z-1224-2024.
Why was it 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.
Which lots are affected?
VITROS System Software Version 3.8.1 Regular UDI-DI 10758750002979 Refurbished UD-DI 10758750007103 Serial Numbers US: J36001167 OUS: J36000427 J36001117 J36001558 J36000580 J36001154 J36001570 J36000626 J36001229 J36001573 J36000688 J36001427 J36001575 J36000877 J36001451 J36001579 J36000920 J36001488 J36001582 J36000929 J36001489 J36001583 J36000942 J36001495 J36001595 J36001012 J36001519 J36001602 J36001051 J36001528 J36001608 J36001108 J36001530 J36001632 J36001111 J36001535 J36001640
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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