ClearanceBrief
Recall Z-2129-2023 ยท JIT Calibrator, Secondary

Ortho-Clinical Diagnostics

VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. Product Code: 6801704

DateJul 11, 2023 (initiated May 8, 2023)
StatusOpen, Classified
ReasonPotential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for IgG; +12.3% for IgA; -6.9% for C3; -6.6% for C4; and -17.8% for transferrin. Falsely elevated or reduced results could be reported depending on the analyte and/or sample concentration.
Root causeUnder Investigation by firm
ActionQuidelOrtho (formerly Ortho Clinical Diagnostics) issued Urgent product correction Notification on 5/8/23. Letter states reason for recall, health risk and action to take: " Immediately discontinue using and discard your remaining inventory of VITROS Calibrator Kit 20, Lot 2022. QuidelOrtho will replace or credit your account. Indicate quantities to be replaced or credited on the attached Confirmation of Receipt form. " If you do not have an alternative lot of VITROS Calibrator Kit 20, you must discontinue reporting patient results using a Lot 2022 calibration. " Upon receipt of your replaceme
Quantity2400 units
DistributionWorldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, 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.