Reported Mar 5, 2014 · Terminated
VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY…
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 Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG.
- Lot codes and dates
- Product Code 1662659
- Lots1) 212 and 2) 292
- Expiry Dates1) 2014-08-31 and 2) 2014-02-28
- Amount recalled
- 19,368 units total (10,328 for lot 212 and 9,040 for lot 292)
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
Why it was recalled
Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample 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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