Recall Z-1545-2014— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-1545-2014
Creator: U.S. Food and Drug Administration
Published: 2013-02-26

Class III · Terminated

Class III FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2013-02-26, terminated 2014-05-06. It names one FDA 510(k) clearance: K091216. Product: CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.. Reason: Device with Sample Interference Notes (SIN) enabled not cleared for US marketing..

Recalling firm: Siemens Healthcare Diagnostics Inc
Classification: Class III
Status: Terminated
Initiated: 2013-02-26
Terminated: 2014-05-06
Firm location: Norwood, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K091216 — CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797Siemens Healthcare Diagnostics·cleared 2009-10-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.