Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90 slides. Fir
FDA device recall Z-0387-05 · posted 2005-01-08 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.
- Action taken
- Letters dated 11/22/2004 issued to customers. End users instructed to manually modify the Reportable and/or Analyzer Ranges; dilute all samples with an initial CRP result greater than 9.0 mg/dL. Distributors instructed to destroy product in-house and to notify end-users to manually modify the Reportable and/or Analyzer Ranges.
- Root cause
- Other
- Status
- Terminated
- Product code
- DCK
- Quantity affected
- Cat. 1926740 - 20,903 boxes; Cat 8097990 - 34,877 boxes
- Distribution
- Nationwide and worldwide distribution. 70% of product was shipped to foreign consignees.
- Date initiated
- 2004-11-22
- Date posted
- 2005-01-08
- Date terminated
- 2005-05-02
- 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 |