FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375790 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma.
- Recall number
- Z-2000-2009
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375790 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma.
- Status
- Terminated
- Initiated
- 2009-04-22
- Posted
- 2009-09-10
- Terminated
- 2009-12-07
- Reason
- The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles.
- Root cause
- Packaging process control
- Action
- Roche Diagnostics Corp. notified Consignees via letter dated April 22, 2009 and instructed to not use excessive force when opening bottles and contact the firm for product replacement instead. A Fax Back Form was included for customers to return via fax to 1-888-345-0480. For further information, contact your Roche Diagnostics representative or call 1-800-428-5074.
- Quantity
- 3,970 bottles of both products
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot Numbers: 15617400 and 15612200.
- 510(k) numbers
- ["K031856"]
- PMA numbers
- not on file
- Product code
- DKB
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- 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