Recall Z-0395-2017 ยท LCP Assay, Glycosylated Hemoglobin
Roche Diagnostics Operations, Inc.
Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190
| Date | Nov 11, 2016 (initiated Oct 4, 2016) |
| Status | Terminated |
| Reason | Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles. This issue occurred over multiple lots. Single cassettes/bottles of the reagents are affected. The issue can lead to erroneously high HbA1c results. If a patient with known diabetes is affected, an erroneously high HbA1c result might lead to therapeutic consequences, such as therapy escalation (introduction of another oral antidiabetic medication or insulin) or increase of the dosage. This can further lead to an increase |
| Root cause | Storage |
| Action | On 10/4/2016, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected Direct Consignees and Distributors via courier. The recall notifications included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Direct Consignee Actions Required " Follow the instructions in the Customer Actions for Prevention/Detection of the Issue section of this Urgent Medical Device Correction (UMDC). " Complete the attached fax form (7184-00-1016) and fax it to 1-844-294-7181. " File this U |
| Quantity | 4976 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072714 | TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM Roche Diagnostics Corp., Apr 18, 2008 |