HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimens
FDA device recall Z-0626-2014 · posted 2014-01-03 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.
- Action taken
- Siemens sent an Urgent Medical Device Recall letter in April 2013 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discard any remaining inventory of the affected product. Siemens will replace any unused inventory at no charge. Customers were asked to complete the attached form and fax it to 302-631-8467 to indicate they have received the information. Customers were asked to retain the letter with their laboratory records and forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local Siemens technical support representative. For questions regarding this recall call 1-800-441-9250.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LCP
- Quantity affected
- 11006 Total
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.
- Date initiated
- 2013-04-22
- Date posted
- 2014-01-03
- Date terminated
- 2014-02-12
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISA HBA1C, MODEL K3105A (K102045) | Siemens Heatlhcare Diagnostics, Inc. | 2011-02-14 |