November 14, 2005

Dear valued customer:

With this letter, Roche Diagnostics would like to inform you about a technical corrective action relating to the ACCU-CHEK Aviva blood glucose meter. The action described concerns only this system.

Roche maintains close contact with its customers around the world through its relationships with healthcare professionals as well as through the ACCU-CHEK Customer Care Centers. We have received one single complaint worldwide describing a clearly identifiable, too low and non-plausible blood glucose reading following a measurement performed on the ACCU-CHEK Aviva blood glucose meter. To date, in Canada, we have received no such reports.

The blood glucose meter is equipped with a high performance processor. Studies have shown that in very rare cases a malfunction between the software and the processor can result in an incorrect reading.

Although no cases have occurred in Canada, it cannot be ruled out that individual systems with this malfunction could be in circulation. The only systems that might be affected are those with serial numbers below 526 10 999 999. The serial number is located on the back of the meter (see example).

With regards to these systems, we would like to inform you about methods of quality checking that can be used to identify the malfunction described above:

• Remove the battery from the rear of the meter and then wait 5 seconds before replacing it. After the battery has been replaced, start the meter with the "ON" button at top right. This will automatically prompt a quality check of the meter. Meters with this fault will not power on.
  
  If the meter powers "on", you can continue to use your ACCU-CHEK Aviva blood glucose meter in the usual manner.
  
  
• We also invite you to perform a control test per mentioned on page 41 of the Accu-Chek Aviva Owner's Manual whenever your test result does not agree with how you feel, and to remove the battery from the meter again.

If you need assistance, please call the ACCU-CHEK Customer Care Center Monday through Friday; 8:00 a.m. to 8:00 p.m. (ET) at 1-800-363-7949. Meters showing the type of fault described will be replaced immediately free of charge.

The actions described above are being conducted with the knowledge of Health Canada.

Despite the extremely low probability of the case described above, all necessary steps for a technical correction have been implemented.

Yours sincerely

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