Recall Z-0752-2020 ยท NBW System, Test, Blood Glucose, Over The Counter
Roche Diabetes Care, Inc.
Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - 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 monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is i
| Date | Dec 30, 2019 (initiated Sep 30, 2019) |
| Status | Terminated |
| Reason | Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System. |
| Root cause | Device Design |
| Action | On October 23, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail for the Accu-Chek Guide blood glucose meters with a serial number below 92311000001. The serial number can be found on the back of the meter, where indicated by the red rectangle in the photo below. It instructs them to: 1) Always have a spare set of batteries. The meter requires two (2) size CR2032 batteries. 2) Be aware that battery life may vary due to factors such as temperature and battery manufacturer. 3) Have a back-up testing method available. 4) If you have questions regarding this noti |
| Quantity | 452,392 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.