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Terminated

CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.

FDA Recall Z-1545-2014 · Posted 2014-05-04

Recalling FirmSiemens Healthcare Diagnostics Inc
Recall StatusTerminated
Product CodeKQO
Date Initiated2013-02-26
Date Terminated2014-05-06
Product Quantity1 unit

Reason for Recall

Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.

Firm Action

On February 26, 2013, a Siemens Field Engineer from Siemens Healthcare visited customer site and disabled the Sample Interference Notes feature on the instrument.

Root Cause

Reprocessing Controls

Distribution Pattern

US Distribution in the state of: CA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091216CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797Siemens Healthcare Diagnostics · 2009-10-09

Official Source

View FDA Recall →

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

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