FDA Medical Device Recalls (openFDA)
Roche Diagnostics Operations, Inc.: COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
- Recall number
- Z-0396-2017
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Product
- COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
- Status
- Terminated
- Initiated
- 2016-10-04
- Posted
- 2016-11-11
- Terminated
- 2017-06-05
- 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.
- 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 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.
- Quantity
- 4976
- Distribution
- Nationwide.
- Lot, serial or model codes
- Not applicable
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PDJ
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28