FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90 slides. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rochester, NY 14626.
- Recall number
- Z-0387-05
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90 slides. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rochester, NY 14626.
- Status
- Terminated
- Initiated
- 2004-11-22
- Posted
- 2005-01-08
- Terminated
- 2005-05-02
- Reason
- Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.
- Root cause
- Other
- Action
- 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.
- Quantity
- Cat. 1926740 - 20,903 boxes; Cat 8097990 - 34,877 boxes
- Distribution
- Nationwide and worldwide distribution. 70% of product was shipped to foreign consignees.
- Lot, serial or model codes
- Coatings 401 thru 419.
- 510(k) numbers
- ["K030626"]
- PMA numbers
- not on file
- Product code
- DCK
- Firm FEI
- 1000136573
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28