Recall Z-1418-2017
Siemens Healthcare Diagnostics, Inc · initiated January 4, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 VistaSystem. Progesterone measurements are used in the diagnosis and treatment of disorders of the ovaries or placenta.
Codes / lots: SMN: 10310305: 75422274 83380274 89389274 99473274 8713275 19796275 30565275 38674275 46515276 55704276 66971276 78934276 80930277; SMN: 10315522: 74355274 80476274 87497274 20274 7772275 14822275 25943275 35303275 43229276 46525276 55505276 67430276 80448276 81415277; SMN: 10333111: 84848274 89946274 14006275 33598275 49907276 66978276
Reason for recall
DHEA-S causes falsely elevated progesterone results.
FDA-determined cause: Nonconforming Material/Component
Action taken
Siemens sent an Urgent Medical Device Correction (UMDC) letter dated January 4, 2017 to all affected Siemens Healthcare Diagnostics customers in the United States dated . An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on January 4, 2017. These letters identified the affected product problem and actions to be taken. For questions contact your local Siemens Customer Care Center or your local Siemens Technical support.
Details
- Recall number
- Z-1418-2017
- Initiated
- January 4, 2017
- Terminated
- July 18, 2019
- Product code
- JLS – Radioimmunoassay, Progesterone
- Quantity
- 76,107
- Distribution
- US Nationwide distribution including Puerto Rico
- Recalling firm
- Siemens Healthcare Diagnostics, Inc, East Walpole, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1419-2017 Class II | Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number:…DHEA-S causes falsely elevated progesterone results. | 01/04/2017Terminated |
| Z-1420-2017 Class II | IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number:…DHEA-S causes falsely elevated progesterone results. | 01/04/2017Terminated |
| Z-1421-2017 Class II | IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number:…DHEA-S causes falsely elevated progesterone results. | 01/04/2017Terminated |