CLASS II Device recall · Reported 22 Oct 2014 · FDA Enforcement Report
Vitros 5600 Integrated System, System Product recalled
Ortho-Clinical Diagnostics is recalling Vitros 5600 Integrated System, System Product, distributed nationwide in the US. The recall was initiated on 8 Sep 2014 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-0078-2015
- FDA event ID
- 69234
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Sep 2014
- FDA classified
- 16 Oct 2014
- Reported
- 22 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Hidden Drug Ingredients
- Device type
- Test Kits & Diagnostics
Timeline
| 8 Sep 2014 | Recall initiated by company | |
| 16 Oct 2014 | Classified by FDA | +38 days |
| 22 Oct 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden).
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Where it was distributed
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
Questions about this recall
Is Vitros 5600 Integrated System, System Product recalled?
Yes. Ortho-Clinical Diagnostics recalled Vitros 5600 Integrated System, System Product on 8 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-0078-2015.
Why was it recalled?
Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden).
Which lots are affected?
Software Version 3.0 and below; Serial Numbers J56000110 - J56001995 (serial numbers are sequential; J Numbers are analogous to serial numbers)
Where was it sold?
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
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.
More recalls from Ortho-Clinical Diagnostics
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|---|---|---|---|---|---|
| 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 |
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