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Terminated

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 Recall Z-1419-2017 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusTerminated
Product CodeJLS
Date Initiated2017-01-04
Date Terminated2019-07-18
Product Quantity1148

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.

K932955CIBA CORNING ACS PROGESTERONE IMMUNOASSAYCiba Corning Diagnostics Corp. · 1993-08-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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