Recall Z-1473-04 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
Ortho-Clinical Diagnostics
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
| Date | Sep 18, 2004 (initiated Jul 28, 2004) |
| Status | Terminated |
| Reason | The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections. |
| Root cause | Other |
| Action | 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. |
| Quantity | Cat 192 6740 - 5,912 cartons x 250 slides; Cat #809 7990 - 10,344 x 90 slides |
| Distribution | 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, Puer |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030626 | VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7 Ortho-Clinical Diagnostics, Inc., Mar 18, 2003 |