Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro d
FDA device recall Z-0745-2013 · posted 2013-01-29 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable calibration slope (m) values (0.97 - 1.03) when using IRON calibrator lots 2DN060 and 2FN063. Lots 2GN068 and 2JN074 may also be impacted but no complaints have been received.
- Action taken
- Siemens sent a "CUSTOMER NOTIFICATION" letter dated December 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Siemens Technical Solutions Center at 1-800-441-9250 or your local Siemens Healthcare Diagnostics representative for assistance with this issue.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JIS
- Quantity affected
- 5999
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-12-20
- Date posted
- 2013-01-29
- Date terminated
- 2014-01-08
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION IRON CALIBRATOR (K060266) | Dade Behring, Inc. | 2006-03-09 |