Class 3 Device Recall VITROS Chemistry Products CRP Slides

• Date Initiated by Firm: October 26, 2016
• Create Date: December 21, 2016
• Recall Status: Terminated on June 22, 2018
• Recall Number: Z-0864-2017
• Recall Event ID: 75692
• 510(K)Number: K953197 K152433
• Product Classification: C-reactive protein, antigen, antiserum, and control - Product Code DCK
• 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
• Code Information: Affected Generations (GENs): 3, 11, 12, 30 through 36
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 513 Technology Blvd; Rochester NY 14626-3601
• For Additional Information Contact: Ortho Care Technical Solutions Center; 800-421-3311
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 124,063 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DCK and Original Applicant = JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.; 510(K)s with Product Code = DCK and Original Applicant = ORTHO CLINICAL DIAGNOSTICS