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
    • 10381181
    • 10381170
  • 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
1lot 453 L2KPW2 kit
2lot 454 L2KPW2 kit
3lot 455 L2KPW2 kit
4lot 456 L2KPW2 kit
5lot 457 L2KPW2 kit
6lot 458 L2KPW2 kit
7lot 459 L2KPW2 kit
8lot 460 L2KPW2 kit
9lot 462 L2KPW2 kit
10lot 463 L2KPW2 kit
11lot 464 L2KPW2 kit
12lot 465 L2KPW2 kit
13lot 467 L2KPW2 kit
14lot 468 L2KPW2 kit
15lot 470 L2KPW2 kit
16lot 471 L2KPW2 kit
17lot 472 L2KPW2 kit
18lot 474; SMN: 10381170: L2KPW6 kit
19lot 453 L2KPW6 kit
20lot 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 18, 2019 · Data as of Sep 19, 6:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.