ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating In
FDA device recall Z-0173-2014 · posted 2013-11-06 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Reason for recall
- PTH Calibrator packaged with only high calibrator.
- Action taken
- Packaging error was brought to Siemens' attention through escalations received from (3) customers in the United States. Internal Investigation confirmed the issue was limited to the five (5) kits distributed to these customers. As the customers were aware of the issue and non affected product was provided to the customers to use during Siemens' investigation, no further communication was warranted.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- CEW
- Quantity affected
- 595 kits total (5 kits with packaging error)
- Distribution
- Nationwide Distribution including MD, PA, and CT.
- Date initiated
- 2013-08-16
- Date posted
- 2013-11-06
- Date terminated
- 2014-02-13
- Location
- East Walpole, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY (K020217) | Bayer Diagnostics Corp. | 2002-03-15 |