—#152530

Product

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 product code: JLS — Radioimmunoassay, Progesterone
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K932955
Affected lot / code info: LKPW1 kit lot 0245 LKPW1 kit lot 0246 LKPW1 kit lot 0247 LKPW1 kit lot 0248 LKPW1 kit lot 0249

Why it was recalled

DHEA-S causes falsely elevated progesterone results.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: US Nationwide distribution including Puerto Rico

Timeline

Recall initiated: 2017-01-04
Terminated: 2019-07-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152530. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.