Recall Z-2187-2018 ยท LFR Glucose Dehydrogenase, Glucose
Roche Diabetes Care, Inc.
Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectivene
| Date | May 9, 2018 (initiated May 7, 2018) |
| Status | Terminated |
| Reason | The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a blood sample; strips not detected once inserted; or a biased result may occur, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result as compared to the actual blood glucose value. |
| Root cause | Equipment maintenance |
| Action | "On May 7, 2018, the firm sent Urgent Medical Device Correction letters to affected Retailers, Suppliers, and Patients. Patients were instructed to check their test strip supply lot numbers against the recalled lots. Any test strips from the affected lots must be discarded. To get replacement test strips, patients should use one of the following options: o For fastest replacement of your product, please submit your request at https://notices.accu-chek.com o Email Accu-Chek Customer Care at accu-chek.care@roche.com and include the following information: your name, full mailing address, phone |
| Quantity | 295,248 |
| Distribution | Worldwide Distribution - US Nationwide distribution. Foreign distribution to Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Barbados Belgium Brazil Bulgaria Canada Chile China Colombia Costa Rica Denmark Dominican Republic El Salvador Finland Georgia Germany Ghana Greece Guatemala Ho |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131029 | ACCU-CHEK AVIVA PLUS TEST STRIP Roche Diagnostics Operations, Inc., Aug 9, 2013 |