Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human
FDA device recall Z-1048-2013 · posted 2013-04-01 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h
- Action taken
- Siemens initiated their recall of this product on February 27, 2013 by sending an Important Customer Notification letter to consignees by FedEx. The letter identified the product, problem, and actions to be taken by the customers.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 2207 total
- Distribution
- Worldwide Distribution.
- Date initiated
- 2013-02-27
- Date posted
- 2013-04-01
- Date terminated
- 2014-01-14
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD (K073604) | Dade Behring, Inc. | 2008-03-13 |