Reported Apr 30, 2014 · Terminated
VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction…
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 · 1000 Lee Road · Rochester, NY · 14606
Is this the product you have?
- VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077
- used in conjunction withVITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Ortho-Clinical Diagnostics, Inc
- Lot codes and dates
- Calibration Data Module Rev. 0168, REF 199 9077 used in conjuction with of VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, Product Code 6802721.
- Amount recalled
- US: 284 units, Ex-US: 4772 units
Where it was sold
Why it was recalled
Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code 199 9077), as CDM 168 does not contain calibration parameters for DT CRSC.
This product could cause temporary or reversible health problems — stop using it.
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