Reported Mar 16, 2016 · Terminated
VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished,…
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 250 Chemistry SystemsCatalog 8132086Unique Device Identifier No. 10758750004409and VITROS 250 RefurbishedCatalog 6801759Unique Device Identifier No. 10758750001330IVD
- Product UsageFor in vitro diagnostic use. The VITROS 250 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides
- Lot codes and dates
- Software Version 9.4 and below
- VITROS 250 Serial Numbers25010043 - 25055306
- VITROS 250 Refurbished Serial Numbers
1,559 of 1,559 codes
250105822501061725010638250107822501105625011074250111762501119225011196250112462501131725011383250114082501143525011448250115172501164725011648250117772501195725012025250120582501206225012073250120782501214025012259250122672501232325012344250124872501250525012521250125742501262925012654250126722501276525012782250128382501293125012938250130362501310025013139250132162501324525013313250133892501339125013448250134732501349725013583250135972501371925013757250137872501379025013870
- Amount recalled
- US: 802; Foreign: 2472
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).
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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