Roche brand AccuData GTS/GTS Plus System Replacement Base/Module; Catalog number 3426050, material number 03426050001.
FDA device recall Z-0883-05 · posted 2005-06-11 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CGA
- Distribution
- Nationwide and Guam.
- Date initiated
- 2005-04-18
- Date posted
- 2005-06-11
- Date terminated
- 2006-03-07
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCUDATA GLUCOSE TEST STATION (K924475) | Boehringer Mannheim Corp. | 1992-10-13 |