Recall Z-0420-2015 ยท LCP Assay, Glycosylated Hemoglobin
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus.
| Date | Nov 21, 2014 (initiated Sep 30, 2014) |
| Status | Terminated |
| Reason | Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP). QC samples may exhibit a similar bias. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent an Urgent Medical Device Correction letter dated September 2014 was provided to all Dimension Vista HbA1c and Dimension HB1C customers who received the affected lots to notify them of the issue, the potential risk to health, and actions to be taken by customers. Customers were instructed to discontinue use of and discard the affected devices. Customers need to review the letter with their Medical Director. Siemens will replace any unused inventoryof the affected lots at no charge. Customers were asked to complete the attached form and fax it to 302-631-7795. Customers should r |
| Quantity | 53, 046 |
| Distribution | Worldwide Distribution: US (nationwide) and internationally to: Canada. |
| FDA record | Open on fda.gov |