FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc: 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.
- Recall number
- Z-1421-2017
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2017-01-04
- Posted
- not on file
- Terminated
- 2019-07-18
- Reason
- DHEA-S causes falsely elevated progesterone results.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 11963
- Distribution
- US Nationwide distribution including Puerto Rico
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K932955"]
- PMA numbers
- not on file
- Product code
- JLS
- Firm FEI
- 1219913
- Firm city
- East Walpole
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28