Recalls / —

—#33656

Product

ACCU-CHEK Inform base unit; catalog no. 3035131.

FDA product code

NBW — System, Test, Blood Glucose, Over The Counter

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K003846, K012210

Affected lot / code info

All units.

Why it was recalled

Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.

Root cause (FDA determination)

Other

Action the firm took

A recall notice dated 6/30/04 was sent to each customer instructing them on proper cleaning methods, asking them to inspect their units for damage, and providing warning stickers for attachment to the base units.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern

Nationwide.

Timeline

Recall initiated

2004-06-30

Posted by FDA

2004-07-20

Terminated

2005-10-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #33656. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.