ClearanceBrief
Recall Z-1295-2021 ยท JIX Calibrator, Multi-Analyte Mixture

Ortho-Clinical Diagnostics, Inc.

VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit Product No: 7541 (UDI 8750005178) All current and new lots B. VITROS Chemistry Products Fe Slides Product No: 1924547 90 S

DateFeb 18, 2021
StatusTerminated
ReasonPotential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and above will be approximately 80 ug/dL lower across the measuring range than other available GENS of VITROS Fe Slides (GENs 22-25).
Root causeProcess design
ActionOrtho Clinical Diagnostics on 18 February 2021 issued Product Correction Notice(Ref. CL2021-054) states reason for correction, health risk and provided the following information: VITROS TIBC results will show a performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26) and above. Specifically, for VITROS TIBC GEN 26 and above, patient and quality control values may shift lower (approximately 80 g/dL across the measuring range) than other available GENS of VITROS Fe Slides (GENs 22-25). To maintain consistent VITROS TIBC GEN to GEN performance, Ortho will be u
Quantity7546 US and 15280 OUS kits
DistributionWorldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.