Recall Z-0883-05 ยท CGA Glucose Oxidase, Glucose
Roche Diagnostics Corp.
Roche brand AccuData GTS/GTS Plus System Replacement Base/Module; Catalog number 3426050, material number 03426050001.
| Date | Jun 11, 2005 (initiated Apr 18, 2005) |
| Status | Terminated |
| 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. |
| Distribution | Nationwide and Guam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924475 | ACCUDATA GLUCOSE TEST STATION Boehringer Mannheim Corp., Oct 13, 1992 |