Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1519-2014 — VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY

U.S. FDA — Device Enforcement · United States · 2014-03-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1519-2014
Date of alert
2014-03-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ortho-Clinical Diagnostics
Product category
device
Product type
Devices
Reported risk: Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with VITROS Specialty Diluent or a patient sample containing a low concentration of CRP. An initial threefold dilution is recommended. Internal testing determined that results using VITROS CRP Slides have the potential for approximately 51% bias using a 3x dilution factor.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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