Device Alert
Problem: In a February 4, 2011, Urgent Field Safety Notice letter posted by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), Ortho-Clinical Diagnostics (OCD) states that it has received reports in which users observed increased signal-to-cutoff (S/C) ratios for negative patient and quality control samples when using the above reagent packs. OCD states that an internal investigation confirmed that the above reagents may generate higher S/C ratios, potentially yielding a higher rate of borderline results or false reactive results. Manufacturer/Regulatory Agency: Designation: Ortho-Clinical Diagnostics Reference No. CL11-040_EU MHRA Reference No. 2011/002/004/601/004 Action Needed: Verify that you have received the February 4, 2011, Urgent Field Safety Notice letter and confirmation of receipt form from OCD. Identify, isolate, and discard any affected product in your inventory. Complete the Confirmation of Receipt form, and return it to OCD using the instructions on the form. Upon receipt of the form, OCD will send your facility replacement product. Until you receive replacement product, OCD recommends that you use an alternative lot of the above reagent packs. OCD also recommends that you discuss any concerns regarding previously reported results with your laboratory medical director or the requesting physician to determine the appropriate course of action. Inform all relevant personnel at your facility of the information in the Urgent Field Safety Notice letter. Forward a copy of the letter to any facility to which you have further distributed affected product. For Further Information: See attached PDF
Tue Mar 01 2011
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