—#38246

Product

Roche brand AccuData GTS Plus System; Catalog number 3000249, material number 03000249001.

FDA product code: CGA — Glucose Oxidase, Glucose
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K924475
Affected lot / code info: All units.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide and Guam.

Timeline

Recall initiated: 2005-04-18
Posted by FDA: 2005-06-11
Terminated: 2006-03-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38246. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.