Roche Diabetes Care, Inc.: Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is int

Is my product affected?

Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in mon

• UPC 08453071001
• UPC 00365702729100

Check against the official notice below — it lists the full affected range.

What happened

Roche Diabetes Care, Inc. is recalling the Accu-Chek Guide Blood Glucose Monitoring System, Model Number 08453071001, due to potential power issues with the device. The recall affects approximately 3,996 units distributed nationwide in the United States and internationally in Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Germany, Denmark, Ecuador, Spain, Finland, France, Great Britain, Greece, Hong Kong, Croatia, Indonesia, India, Italy, Japan, South Korea, Lebanon, Lithuania, Luxembourg, Myanmar, Malaysia, Netherlands, Norway, Philippines, Pakistan, Portugal, Sweden, Singapore, Thailand, Taiwan, and South Africa.

The affected devices are identified by Model Number 08453071001 and Device Identifier 00365702729100, specifically units with serial numbers below XXX11000001 (where XXX represents the first three digits of the serial number). The recall record does not specify a remedy or corrective action for consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.

Details from the source

Reason for recall: Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Distribution: US Nationwide distribution and countries of AR, AT, AU, BE, BR, CA, CH, CL, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, ID, IN, IT, JP, KR, LB, LT, LU, MM, MY, NL, NO, PH, PK, PT, SE, SG, TH, TW, ZA. Quantity: 3,996 Lot/code info: Model Number : 08453071001 Device Identifier: 00365702729100 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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