FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company.
- Recall number
- Z-0919-03
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company.
- Status
- Terminated
- Initiated
- 2003-03-26
- Posted
- 2003-06-05
- Terminated
- 2004-11-16
- Reason
- Slides may exhibit random, elevated imprecision of results.
- Root cause
- Other
- Action
- Notification via letter dated 3/26/03 with instructions to discard product.
- Quantity
- 29,273 (domestic); 4,967 (international)
- Distribution
- Nationwide and Worldwide.
- Lot, serial or model codes
- All slide lots with coatings ''0292'' and ''0293''. The coating lot numbers are seen as ''xxxx-0292-xxxx'' and ''xxxx-0293-xxxx'' in the lot number.
- 510(k) numbers
- ["K812028"]
- PMA numbers
- not on file
- Product code
- CEK
- 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