FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche brand AccuData GTS/GTS Plus System Replacement Base/Module; Catalog number 3426050, material number 03426050001.
- Recall number
- Z-0883-05
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche brand AccuData GTS/GTS Plus System Replacement Base/Module; Catalog number 3426050, material number 03426050001.
- Status
- Terminated
- Initiated
- 2005-04-18
- Posted
- 2005-06-11
- Terminated
- 2006-03-07
- Reason
- If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.
- Root cause
- Other
- Action
- Consignees were notified via letter dated 4/18/05, which included instructions on how to inspect their unit for damage, and how to prevent future damage.
- Quantity
- not on file
- Distribution
- Nationwide and Guam.
- Lot, serial or model codes
- All units.
- 510(k) numbers
- ["K924475"]
- PMA numbers
- not on file
- Product code
- CGA
- 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