—#126556

Product

VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY, 14626

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K962235
Affected lot / code info: Lot 01-3266 (exp. 23-SEPTEMBER-2014)

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

On 3/26/2014, Urgent Product Correction Notification Letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected lot(s), discard the affected lots and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. Replacement product will be sent for the product discarded. J&J Foreign affiliate consignees were notified by e-mail informing them of the issue on 3/26/2014.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

Distribution pattern: Nationwide, Puerto Rico, and foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.

Timeline

Recall initiated: 2014-03-26
Posted by FDA: 2014-04-28
Terminated: 2017-03-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126556. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.