The Recall Desk
HighFDA (Devices)·Z-2129-2023·Announced 2023-07-19

Ortho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Calibrator Kit 20 due to measurement bias affecting laboratory results for immunoglobulin and complement protein testing. Falsely elevated or reduced values could be reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II designation applies. While no hospitalizations or reported injuries have been documented, the measured biases (ranging from -17.8% to +35.3%) represent significant analytical error with potential for patient harm through incorrect diagnostic results, classifying this as a risk-of-harm device without yet-reported injury.

Plain-English summary

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 20 (Product Code 6801704), used to calibrate VITROS 5,1 FS/4600 and 5600/XT 7600 chemistry analyzers. The recall affects approximately 2,400 units distributed worldwide, including the US, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and the United Kingdom.

The calibrator kit can produce biased results in the upper end of the reportable range for quantitative measurement of transferrin, C3, C4, IgA, IgG, and IgM. Observed measurement biases in sample testing included: IgM +35.3%, IgG -4.3%, IgA +12.3%, C3 -6.9%, C4 -6.6%, and transferrin -17.8%. Depending on the analyte and sample concentration, laboratory results may be falsely elevated or reduced.

Affected lot code is 2022 with expiration date 06-Sept-2023 (UDI-DI: 10758750006687). Clinical laboratories using this calibrator kit should contact Ortho-Clinical Diagnostics for replacement or validation guidance. Results from affected calibrations should be reviewed for accuracy, particularly for immunoglobulin and complement protein measurements.

The recalled product

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, C
Manufacturer
Ortho-Clinical Diagnostics
Category
Medical Device — Laboratory Diagnostic Equipment
Hazard
  • measurement-bias
  • inaccurate-results

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

Related recalls

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