—#151060

Product

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

FDA product code: DCK — C-Reactive Protein, Antigen, Antiserum, And Control
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K152433, K953197
Affected lot / code info: Affected Generations (GENs): 3, 11, 12, 30 through 36

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

Ortho Clinical Diagnostics sent an Important Product Correction Notification dated October 26, 2016., via FedEx overnight courier and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who do NOT use ORTHO PLUS e-Communications and received CRP slides within the last 12 months to inform them of the possibility of positively biased CRP results when using VITROS CRP Slides with diluted samples and to provide them with original instructions for how to perform dilutions when processing CRP samples with concentrations above the measuring range. On 1 November 2016, Ortho Clinical Diagnostics issued customer letter (Ref. CL2016-209) sent via ORTHO PLUS e-Communications to all customers who use ORTHO PLUS e-Communications and received CRP slides within the last 12 months to inform them of the possibility of positively biased CRP results when using VITROS CRP Slides with diluted samples and to provide them with two revised instructions on how to perform dilutions when processing CRP samples with concentrations above the measuring range. Foreign affiliates were informed by email on October 26, 2016, of the issue and instructed to notify their consignees of the issue. This included the original instructions for how to perform dilutions when processing CRP samples with concentrations above the measuring range. On 1 November 2016, two revised Instructions for CRP Dilutions enclosures (Ref. CL2016-209) were sent via FedEx overnight courier and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received CL2016-209 via FedEx overnight courier or US Postal Service Priority Mail that provided additional detailed instructions on how to perform a dilution for samples exceeding the measuring range. If you have further questions, please contact our Ortho Care Technical Solutions Center at 1-800-421-3311.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 513 Technology Blvd, Rochester, New York 14626-3601

Distribution

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.

Timeline

Recall initiated: 2016-10-26
Terminated: 2018-06-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151060. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.