The Recall Desk
HighFDA (Devices)·Z-0535-2025·Announced 2024-12-04

VITROS Chemistry CRP Diagnostic Slides May Underreport Elevated Results

Ortho-Clinical Diagnostics is recalling 7,717 units of VITROS CRP diagnostic slides that may produce falsely low results for high C-reactive protein samples, risking missed diagnosis of infection or inflammation.

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: This is an FDA Class II recall of a diagnostic test device with a measurable risk of producing false results that could delay clinical diagnosis. Although no injuries or illnesses have been reported, the device qualifies as a risk-of-harm product—misreporting elevated CRP levels could delay treatment for serious infections or inflammatory conditions.

Plain-English summary

Ortho-Clinical Diagnostics, Inc. is recalling 7,717 units of VITROS Chemistry Products CRP Slides (Model 1926740, UDI/GTIN 10758750000296) distributed worldwide, including across US states and multiple countries.

The VITROS CRP Slides are in vitro diagnostic devices used to quantitatively measure C-reactive protein (CRP) concentration in serum and plasma. These slides are used in clinical laboratories to assess inflammation and infection.

The affected slides may generate negatively biased (falsely low) results when testing samples with elevated CRP concentrations, particularly in the 70–90 mg/L range and above. There is no way for users to recognize that a sample result may be inaccurate or to determine whether the sample requires dilution and re-testing. This can result in underestimation of CRP levels and potential delays in clinical diagnosis.

Healthcare providers and laboratories currently using these slides should discontinue use. The recall affects slides with Coating 1221 (expiration date 10/01/2024) and Coating 1222 (expiration date 01/01/2025). Users should contact Ortho-Clinical Diagnostics for additional information and instructions.

The recalled product

Product
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
Manufacturer
Ortho-Clinical Diagnostics, Inc.
Category
Medical Device — Laboratory Diagnostics / In Vitro Diagnostic
Hazard
  • measurement-bias
  • diagnostic-error
  • false-low-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 (3)

  • UDI/GTIN 10758750000296 Coating 1221
  • expiration date 10/01/2024 Coating 1222
  • expiration date 01/01/2025

Distribution

Distributed nationwide across the United States.

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