Device Recall ACCUCHEK

For the quantitative measurement of the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.

Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04528247001. (Distributed within the U.S.)

Aviva meter serial numbers 52500000000 through 52510999999.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.

Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532275001. (Distributed within the U.S.)

Aviva meter serial numbers 52600000000 through 52610999999, 52700000000 through 52710999999 and 52800000000 through 52810999999.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.

Roche brand Accu-Chek Aviva Meter (mmol/L); Catalog numbers 03532313001 and 03532321001. (Distributed outside of the U.S.)

All lots.

Clinical Chemistry and Clinical Toxicology Devices

2

No

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.

Accu-Chek Inform blood glucose test strips; Reference numbers 04535057001, 04647696001 and 04535120001 (All sold outside of the United States).

Lots 31069UF, 31089UF, 3C097UF, 3D073UF, 3D129UF, 3E046UF, 3F010UF, 3F067UF, 3F068UF, 3F126UF, 3G007UF, 3G152UF, 3G172UF, 3H003UF, 3I145UF, 3J025UF, 3J183UF, 3K056UF, 3L052UF, 3L065UF, 4A088UF, 4C121UF, 4D097UF, 4D108UF, 4E084UF, 4E159UF, 4F097UF, 4F174UF, 4G101UF, 4H038UF, 4H112UF, 4I007UF, 4I161UF, 4I183UF, 4J116UF, 4K043UF, 4L045UF, 5C036UF, 5D185UF, 5E031UF, 5F158UF, 5F192UF, 5H136UF, 5I072UF, 5I120UF, 5J173UF, 5K005UF, 5K080UF, 5K105UF and 6B068UF.

General Hospital and Personal Use Devices

2

No

Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Accu-Chek Ultraflex 1-infusion set; 8 mm 24'' (60 cm); Catalog Number INF 04540786001.