Ortho-Clinical Diagnostics: Medical Device Recall in 2016 - (Recall #: Z-0864-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740

Product Classification:

Class III

Date Initiated: October 26, 2016

Date Posted: December 28, 2016

Recall Number: Z-0864-2017

Event ID: 75692

Reason for Recall:

CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biased results if the endogenous level of CRP in the diluent is not subtracted from the final result. The IFUs do not provide specific instructions for how to account for endogenous CRP in the diluent when calculating the sample result. Orthos diluents used to dilute samples containing CRP are manufactured using human plasma based fluids that contain endogenous CRP. Without accounting for the CRP in the diluent and removing its contribution from the result, the reported result will include the CRP present in both the sample and diluent, possibly leading to positively biased results.

Status: Terminated

Product Quantity: 124,063 units

Code Information:

Affected Generations (GENs): 3, 11, 12, 30 through 36

Distribution Pattern:

Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico, and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.

Voluntary or Mandated:

Voluntary: Firm initiated