Reported Oct 17, 2018 · Terminated
VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative…
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- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest
- Catalog Number6802915
- Lot codes and dates
- Serial NumbersUS:
66 of 66 codes
560007185600106256000458560008245600031556001235560007865600074756000339560005595600030856000727560007415600079256000750560008255600101256001641560011315600081856000327560006615600025556001021560005335600111156001689560011525600114156000756560005855600042756000261560015705600153556001139560003175600118456001530560015585600133456001437560008835600144556000186560003085600031556000327560003395600045856000559560007185600072756000741560007475600075056000786560007925600082456000825
- OUSSerial No
76 of 76 codes
560003625600052856000245560002835600033056000377560003995600041356000437560004645600063456000740560007405600074956000758560007585600075956000759560008265600124656001461560014615600043856000414560004165600052856000555560006425600056056000537560008675600051556001487560002005600033156000428560004635600046656000632560009235600041656000567560014875600053956000459560006425600066956001482560004395600055556000147560001795600021456000260560002775600041556000426560005355600058256000680
- Serial NumbersUS:
- Amount recalled
- U.S.= 66 ex-U.S.= 76
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
Why it was recalled
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
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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