Reported Apr 13, 2016 · Terminated
VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in…
Ortho-Clinical Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- 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.
- Lot codes and dates
- Product Codes
68024136802915 (Refurbished)
- Serial numbersJ56000024 - J56002387
- Product Codes
- Amount recalled
- 2,101 Total units (1,043 domestically & 1,058 internationally)
Where it was sold
- Nationwide
- PR
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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