VITROS Chemistry Products Specialty Diluent recall
VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
Why was VITROS Chemistry Products Specialty Diluent 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot F3168 (exp. 30 Sep 2014)
- Product
- VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 1656 distributed (1200 went to warehouse in France)
- Distribution
- 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.
- Recall date
- May 7, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)