Recall Z-0864-2017 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
Ortho-Clinical Diagnostics
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
| Date | Oct 26, 2016 |
| Status | Terminated |
| Reason | 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 rem |
| Root 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 Cli |
| Quantity | 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. |
| FDA record | Open on fda.gov |