CLASS II ONGOING Device recall · Reported 13 Mar 2024 · FDA Enforcement Report
Vitros XT 7600 Integrated System recalled by Ortho-Clinical Diagnostics
Ortho-Clinical Diagnostics is recalling Vitros XT 7600 Integrated 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-1228-2024
- 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
- Other Medical Devices
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 XT 7600 Integrated System, Catalog No. 6844461
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
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 UDI-DI 10758750031610 Serial Numbers US: J76000199 J76001383 J76000207 J76001385 J76000353 J76001392 J76000456 J76001404 J76000459 J76001406 J76000460 J76001516 J76000468 J76001518 J76000495 J76001519 J76000502 J76001520 J76000561 J76001581 J76001207 J76001583 J76001230 J76001611 J76001231 J76001620 J76001232 J76001644 J76001235 J76001647 J76001239 J76001660 J76001260 J76001668 J76001263 J76001671 J76001270 J76001674 J76001274 J76001692 J76001331 J76001700 J76001351 J76001748 OUS: J76000118 J76001070 J76000253 J76001074 J76000265 J76001095 J76000274 J76001121 J76000281 J76001130 J76000370 J76001152 J76000447 J76001174 J76000475 J76001328 J76000620 J76001377 J76000855 J76001378 J76000856 J76001396 J76000898 J76001399 J76000901 J76001407 J76000973 J76001408 J76000976 J76001484 J76001001 J76001673 J76001027 J76001761 J76001035
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 93925This product is part of a recall event; the main page for the event is Vitros 5600 Integrated System recalled by Ortho-Clinical Diagnostics.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Vitros 5600 Integrated System recalled by Ortho-Clinical Diagnostics | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide | |
| CLASS II | Vitros XT 3400 Chemistry System recalled by Ortho-Clinical Diagnostics | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide | |
| CLASS II | Vitros 3600 Immunodiagnostic System recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide | |
| CLASS II | Vitros 4600 Chemistry System recalled by Ortho-Clinical Diagnostics | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
More recalls from Ortho-Clinical Diagnostics
All 311| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products LAC Slides recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products Ca Slides recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products CHE Slides (Japan) recalled | Ortho-Clinical Diagnostics | Labeling Errors | Nationwide |
| Device | CLASS II | Vitros Chemistry Products CHE Slides recalled | Ortho-Clinical Diagnostics | Labeling Errors | Nationwide |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |