COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160

FDA device recall Z-0396-2017 · posted 2016-11-11 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

Reason for recall

.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.

Action taken

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 (2-8C) 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.

Root cause

Storage

Status

Terminated

Product code

PDJ

Quantity affected

4976

Distribution

Nationwide.

Date initiated

2016-10-04

Date posted

2016-11-11

Date terminated

2017-06-05

Location

Indianapolis, IN