FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 14626.
- Recall number
- Z-0866-05
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 14626.
- Status
- Terminated
- Initiated
- 2005-04-18
- Posted
- 2005-06-04
- Terminated
- 2005-10-13
- Reason
- Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.
- Root cause
- Other
- Action
- Letters dated 4/18/2005 with instructions to process a mid-level QC fluid every eight hours when processing patient samples for valproic acid. Replacement product to be shipped as soon as available.
- Quantity
- 139 boxes
- Distribution
- 37 U.S. consignees nationwide. Ortho-Clinical foreign affiliates in England, France and Spain.
- Lot, serial or model codes
- 01-5871, Exp. 31Jan06
- 510(k) numbers
- ["K042476"]
- PMA numbers
- not on file
- Product code
- LEG
- 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