CLASS II Device recall · Reported 15 Mar 2017 · FDA Enforcement Report

Immulite 2000 Progesterone recalled by Siemens Healthcare Diagnostics

Siemens Healthcare Diagnostics is recalling Immulite 2000 Progesterone, distributed nationwide in the US. The recall was initiated on 4 Jan 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSMN: 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

Quantity recalled11963

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1421-2017
FDA event ID: 76212
Recalling firm: Siemens Healthcare Diagnostics, East Walpole, MA
Classification: Class II
Status: Terminated
Recall initiated: 4 Jan 2017
FDA classified: 9 Mar 2017
Reported: 15 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

4 Jan 2017	Recall initiated by company
9 Mar 2017	Classified by FDA	+64 days
15 Mar 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

DHEA-S causes falsely elevated progesterone results.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution including Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Is Immulite 2000 Progesterone recalled?

Yes. Siemens Healthcare Diagnostics recalled Immulite 2000 Progesterone on 4 Jan 2017. The recall is Class II and its status is Terminated. Recall number Z-1421-2017.

Why was it recalled?

DHEA-S causes falsely elevated progesterone results.

Which lots are affected?

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

Where was it sold?

US Nationwide distribution including Puerto Rico

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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