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U.S. Department of Health and Human Services

Class 2 Device Recall cobas INTEGRA 800 TinaQuant Hemoglobin A1cDX Gen.2

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  Class 2 Device Recall cobas INTEGRA 800 TinaQuant Hemoglobin A1cDX Gen.2 see related information
Date Initiated by Firm October 04, 2016
Date Posted November 11, 2016
Recall Status1 Terminated 3 on June 05, 2017
Recall Number Z-0396-2017
Recall Event ID 75366
510(K)Number K121291  
Product Classification Hemoglobin A1c test system - Product Code PDJ
Product COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test
Catalog number 04528123160
Code Information Not applicable
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Support Network Customer Support C
800-428-2336
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 4976
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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