FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.
- Recall number
- Z-0913-05
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.
- Status
- Terminated
- Initiated
- 2005-03-15
- Posted
- 2005-06-21
- Terminated
- 2006-02-10
- Reason
- Potential for positively biased results in QC and patient samples.
- Root cause
- Other
- Action
- Letters dated 3/15/2005 sent First Class Mail. Customers are advised product will be replaced. The letter includes modified quality control procedures that will pre-qualify each reagent pack.
- Quantity
- Domestic - 1359; International - 840
- Distribution
- Nationwide distribution. Product shipped worldwide via J&J foreign affiliates.
- Lot, serial or model codes
- Lot 710, Exp. 7/28/05
- 510(k) numbers
- K964721
- PMA numbers
- not on file
- Product code
- KLI
- 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