FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 ****
- Recall number
- Z-0557-03
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 ****
- Status
- Terminated
- Initiated
- 2002-12-18
- Posted
- 2003-02-21
- Terminated
- 2003-04-14
- Reason
- Cartons labeled 'TDM Performance Verifier I' may contain TDM Performance Verified II.
- Root cause
- Other
- Action
- Letters dated 12/18/02 with instructions to inspect inventory and to discard affected product.
- Quantity
- 1,338 cartons
- Distribution
- Nationwide distribution to medical facilities, distributors, and U.S. government consignees (39).
- Lot, serial or model codes
- T3606, Exp 31 Mar 2004
- 510(k) numbers
- ["K013899"]
- PMA numbers
- not on file
- Product code
- not on file
- 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