Reported Mar 15, 2017 · Terminated
IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage:…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc · 333 Coney St · East Walpole, MA · 02032-1516
Is this the product you have?
- IMMULITE 2000 Progesterone
- Catalog NumberL2KPW2 L2KPW6
- Siemens Material Number
1038118110381170
- Product UsageFor 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
- Lot codes and dates
37 of 37 products
Products covered by this recall # Product as published 1 lot 453 L2KPW2 kit 2 lot 454 L2KPW2 kit 3 lot 455 L2KPW2 kit 4 lot 456 L2KPW2 kit 5 lot 457 L2KPW2 kit 6 lot 458 L2KPW2 kit 7 lot 459 L2KPW2 kit 8 lot 460 L2KPW2 kit 9 lot 462 L2KPW2 kit 10 lot 463 L2KPW2 kit 11 lot 464 L2KPW2 kit 12 lot 465 L2KPW2 kit 13 lot 467 L2KPW2 kit 14 lot 468 L2KPW2 kit 15 lot 470 L2KPW2 kit 16 lot 471 L2KPW2 kit 17 lot 472 L2KPW2 kit 18 lot 474; SMN: 10381170: L2KPW6 kit 19 lot 453 L2KPW6 kit 20 lot 454 L2KPW6 kit - Amount recalled
- 11963
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
DHEA-S causes falsely elevated progesterone results.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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