FDAFDA · Food and drugs·Recall number Z-1421-2017
IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.
Published March 15, 2017 · Recall initiated: January 4, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
DHEA-S causes falsely elevated progesterone results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Distributor
- US Nationwide distribution including Puerto Rico
- Lot
- SMN: 10381181: L2KPW2 kit lot 453 L2KPW2 kit lot 454 L2KPW2 kit lot 455 L2KPW2 kit lot 456 L2KPW2 kit lot 457 L2KPW2 kit lot 458 L2KPW2 kit lot 459 L2KPW2 kit lot 460 L2KPW2 kit lot 462 L2KPW2 kit lot 463 L2KPW2 kit lot 464 L2KPW2 kit lot 465 L2KPW2 kit lot 467 L2KPW2 kit lot 468 L2KPW2 kit lot 470 L2KPW2 kit lot 471 L2KPW2 kit lot 472 L2KPW2 kit lot 474; SMN: 10381170: L2KPW6 kit lot 453 L2KPW6 kit lot 454 L2KPW6 kit lot 455 L2KPW6 kit lot 456 L2KPW6 kit lot 457 L2KPW6 kit lot 458 L2KPW6 kit lot 459 L2KPW6 kit lot 460 L2KPW6 kit lot 461 L2KPW6 kit lot 463 L2KPW6 kit lot 464 L2KPW6 kit lot 465 L2KPW6 kit lot 466 L2KPW6 kit lot 467 L2KPW6 kit lot 469 L2KPW6 kit lot 470 L2KPW6 kit lot 471 L2KPW6 kit lot 472 L2KPW6 kit lot 474
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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