ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used in the diagnosis and treatment of disorders of the ovaries or placenta.
Reported: March 15, 2017 Initiated: January 4, 2017 #Z-1418-2017
Product Description
ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used in the diagnosis and treatment of disorders of the ovaries or placenta.
Reason for Recall
DHEA-S causes falsely elevated progesterone results.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 76,107
- Distribution
- US Nationwide distribution including Puerto Rico
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used in the diagnosis and treatment of disorders of the ovaries or placenta.. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 76,107.
Why was this product recalled? ▼
DHEA-S causes falsely elevated progesterone results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 15, 2017. Severity: Moderate. Recall number: Z-1418-2017.
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