Recalls / —
—#121533
Product
ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
- FDA product code
- CEW — Radioimmunoassay, Parathyroid Hormone
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K020217
- Affected lot / code info
- Kit Lot: 14136A16 04 Mar 2014
Why it was recalled
PTH Calibrator packaged with only high calibrator.
Root cause (FDA determination)
Packaging
Action the firm took
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.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc
- Address
- 333 Coney St, East Walpole, Massachusetts 02032-1516
Distribution
- Distribution pattern
- Nationwide Distribution including MD, PA, and CT.
Timeline
- Recall initiated
- 2013-08-16
- Posted by FDA
- 2013-11-06
- Terminated
- 2014-02-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #121533. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.