Reported Jun 15, 2016 · Terminated
VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600…
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?
3 of 3 products
| Model / number | Barcodes | Product as published |
|---|---|---|
6802413 | 10758750002740 | VITROS 5600 Integrated System, , Unique Device Identifier No. 10758750002740 |
6802915 | 10758750007110 | and VITROS 5600 Integrated System (refurbished), , Unique Device Identifier No. 10758750007110 |
| — | IVD. |
- Lot codes and dates
- Software Version 3.2.2 & below; VITROS 5600 Serial Numbers J56000024 - J56002387; VITROS 5600 (Refurbished)
- US Serial Numbers
56000186560003085600031556000327560003395600045856000559560007185600072756000741560007475600075056000786560007925600082456001062560012355600163556001641
- Foreign Serial Numbers56000147, 56000200, 56000214, 56000245,56000283, 56000330, 56000331, 56000362, 56000377, 56000399, 56000413, 56000416, 56000428, 56000437, 56000438, 56000439, 56000459, 56000463, 56000464, 56000466, 56000515, 56000528, 56000537, 56000555, 56000560, 56000632, 56000642, 56000669, 56000680, 56000749, 56000867, 56001133, 56001135, 56001246, 56001461, 56001482, 56001487, 56001859. Unique Device Identifier No. 10758750002740
- Amount recalled
- VITROS 5600: US: 1161 units, Foreign: 1063 units; VITROS 5600 Refurbished: US: 19 units, Foreign: 38 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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