—#34728

Product

VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are for use on the Vitros 250/250AT and/or Vitros 950/950AT Clinical Chemistry Systems. For in vitro diagnostic use. Vitros CRP slides quantitatively measure C-reactive protein concentration in serum and plasma.

FDA product code: DCK — C-Reactive Protein, Antigen, Antiserum, And Control
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K030626
Affected lot / code info: Coatings 401 thru 409 (Generations 92, 93, 94, 99, 01, 02, 03, 04, and 05)

Why it was recalled

The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections.

Root cause (FDA determination)

Other

Action the firm took

Letters dated 7/28/2004. Distributors instructed to destroy product. Users instructed to use revised IR wash tolerance values (provided with letter). A Calibration Diskette, Data Release Version 5384 will also be provided to end users.

Recalling firm

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

Distribution

Distribution pattern: DOMESTIC distribution (nationwide): Product shipped to 6 distributors, 140 hospitals, and 6 U.S. government accounts. FOREIGN distribution: Product shipped to 22 Ortho-Clinical/J&J affiliates in Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Peru, Ecuador, India, Japan, Mexico, Puerto Rico, Panama, Singapore, Venezuela, England, France, Germany, Italy and Spain. The foreign affiliates further distributed product.

Timeline

Recall initiated: 2004-07-28
Posted by FDA: 2004-09-18
Terminated: 2005-06-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34728. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.