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VITROS recallZ-2129-2023 · Ortho-Clinical Diagnostics · initiated May 8, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ortho-Clinical Diagnostics or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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 details

Recall number
Z-2129-2023
Status
Open, Classified
Initiated by the company
May 8, 2023
Posted by the FDA
Jul 11, 2023
Recalling firm
Ortho-Clinical Diagnostics
Quantity
2400 units
Product code
JIT
Distribution
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.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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