—#152529

Product

Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems

FDA product code: JLS — Radioimmunoassay, Progesterone
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K932955
Affected lot / code info: 16193BB 16200BA 16214BA 16235BB 16250BA 16270BA 16291BA 16319AA

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 #152529. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.