VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label:
FDA device recall Z-1473-04 · posted 2004-09-18 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DCK
- Quantity affected
- 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 Argen
- Date initiated
- 2004-07-28
- Date posted
- 2004-09-18
- Date terminated
- 2005-06-09
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7 (K030626) | Ortho-Clinical Diagnostics, Inc. | 2003-03-18 |