Recalls / —

—#126623

Product

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

FDA product code

KQO — Automated Urinalysis System

Device class

Class 1

Medical specialty

Clinical Chemistry

510(k) numbers

K091216

Affected lot / code info

Serial Number: 212809

Why it was recalled

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

Root cause (FDA determination)

Reprocessing Controls

Action the firm took

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

Recalling firm

Firm

Siemens Healthcare Diagnostics Inc

Address

2 Edgewater Drive, Norwood, Massachusetts 02062

Distribution

Distribution pattern

US Distribution in the state of: CA.

Timeline

Recall initiated

2013-02-26

Posted by FDA

2014-05-04

Terminated

2014-05-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #126623. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.