Recall Z-0636-2013— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-0636-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-21

Class III · Terminated

Class III FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2012-11-21, terminated 2014-11-06. It names one FDA 510(k) clearance: K943780. Product: Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS¿ Automated urine Chemistry Analyzer and CLINITEK ATLAS¿ 10 reagent Pak, CLINITEK ATLAS¿ Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. Each CLINITEK ATLAS Positive Control Strip is a firm plastic strip to which are affixed seven separate analyte areas.. Reason: When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F)..

Recalling firm: Siemens Healthcare Diagnostics Inc
Classification: Class III
Status: Terminated
Initiated: 2012-11-21
Terminated: 2014-11-06
Firm location: Norwood, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K943780 — NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)Heraeus Kulzer, Inc.·cleared 1994-10-31

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

Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS¿ Automated urine Chemistry Analyzer and CLINITEK ATLAS¿ 10 reagent Pak, CLINITEK ATLAS¿ Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. Each CLINITEK ATLAS Positive Control Strip is a firm plastic strip to which are affixed seven separate analyte areas.

Reason for recall

When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).

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