FDAFDA · Food and drugs·Recall number Z-2183-2014
VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma.
Published August 20, 2014 · Recall initiated: July 16, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Customers may receive positively biased results when using VITROS¿ Immunodiagnostic Products CA 19-9 Total Reagent Packs, Lot 1320 and VITROS¿ CA 19-9 Calibrators, Lot 1320 on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. There is an unexpected observed change in CA 19-9 Calibrators, Lot 1320 calibrator values.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to France and Japan
- Lot
- Lot 1320, Product code: 6800035 and 6800040
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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