—#44005

Product

Accu-Chek Advantage Pro blood glucose test strips; Reference number 04534972001 (All sold outside of the United States).

FDA product code: LFR — Glucose Dehydrogenase, Glucose
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K982089
Affected lot / code info: All lots.

Why it was recalled

There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.

Root cause (FDA determination)

Other

Action the firm took

Notifications (letters) dated 2/10/06 were sent to healthcare professionals, retail pharmacies, hospitals and mail order firms asking them to provide their customers with information instructing the users to inspect their strip vials and to not use strips from defective vials. Mail order accounts were instructed to forward the recall notification to end users.

Recalling firm

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

Distribution

Distribution pattern: Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, England, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan and Thailand.

Timeline

Recall initiated: 2006-02-10
Posted by FDA: 2006-02-28
Terminated: 2007-02-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #44005. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.