VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only…

Date

July 19, 2023

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Ortho-Clinical Diagnostics

Product

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

Reason

Potential 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.

Distribution pattern

Worldwide 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.

Quantity

2400 units

Codes and lots

UDI-DI: 10758750006687 Lot Code: 2022 Exp. Date :06-Sept-2023

Recall started

May 8, 2023

Device type

Calibrator, Secondary

Root cause (FDA)

Under Investigation by firm

What the company told customers

QuidelOrtho (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 replacement lot of VITROS Calibrator Kit 20, re-calibrate VITROS Transferrin, C3, C4, IgA, IgG and/or IgM assays on your VITROS System. " Complete the enclosed Confirmation of Receipt form . " Please forward this notification if the affected product was distributed outside of your facility. " Post this notification by your VITROS System(s) or with the user documentation until you receive your replacement order. Resolution Once we receive your completed Confirmation of Receipt form, QuidelOrtho will process your replacement order or credit your account. To provide replacement product for all customers, product allocation may be necessary. Contact Information . If you have further questions, please contact our Ortho Care Technical Solutions Center

Recall number

Z-2129-2023

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2129-2023. The agency record governs; check it and the company before acting.