Rappel de Tinaquant Hemoglobin A1c Gen.2

Recall

75366

Class 2

Z-0395-2017

2016-10-04

2016-11-11

Terminated

United States

2017-06-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150149

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 increased risk of hypoglycemia. considering the unreliable detectability of the issue, relevant medical risk for the patient cannot entirely be excluded.

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 Urgent Medical Device Correction (UMDC) for future reference. Questions Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC. Distributor Actions Required " Ensure proper storage conditions (2-8¿C) are maintained for the reagents listed in the table above, per their respective method sheet. " If you have not directly shipped any of the products in the table above, you do not need to distribute the enclosed UMDC to your customers. " If you have directly shipped any of the products in the table above, please distribute the enclosed UMDC 16-157 to those customers. " Complete the attached fax form (7185-00-1016) and fax it to 1-844-294-7181. Questions Please contact the Roche Support Network Customer Support Center at 1-800-428-2336 if you have questions about the information contained in this distributor letter or the enclosed UMDC 16-157.