CLASS II Device recall · Reported 13 Apr 2016 · FDA Enforcement Report
Vitros 5600 Integrated System recalled by Ortho-Clinical Diagnostics
Ortho-Clinical Diagnostics is recalling Vitros 5600 Integrated System, Unique Device Identifier No. 10758750002740 &, distributed nationwide in the US. The recall was initiated on 16 Feb 2016 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-1348-2016
- FDA event ID
- 73429
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Feb 2016
- FDA classified
- 7 Apr 2016
- Reported
- 13 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 16 Feb 2016 | Recall initiated by company | |
| 7 Apr 2016 | Classified by FDA | +51 days |
| 13 Apr 2016 | 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
The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.
Product as listed by the FDA
VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.
Where it was distributed
Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.
Questions about this recall
Why was it recalled?
The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.
Which lots are affected?
Product Codes: 6802413, 6802915 (Refurbished) Serial numbers: J56000024 - J56002387
Where was it sold?
Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.
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.
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