IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.
FDA Recall Z-1420-2017 · Posted None
Advertisement
Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusTerminated
Product CodeJLS
Date Initiated2017-01-04
Date Terminated2019-07-18
Product Quantity9076
Reason for Recall
DHEA-S causes falsely elevated progesterone results.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution including Puerto Rico
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement