Z-0636-2013Class II

Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When...

Name: Z-0636-2013 Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When...
Creator: Siemens Healthcare Diagnostics Inc
Published: 2012-11-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-11-21 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics Inc began a recall of Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS Automated urine... on 2012-11-21. FDA classified it as Class II and gives the reason as "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 25C (77F)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0636-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-21
Posted: 2013-01-04
Terminated: 2014-11-06
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JJW Urinalysis Controls (Assayed And Unassayed)
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 25C (77F).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens issued An Urgent Field Safety Notice via e-mail to all affected SiemensHealthcare Diagnostics Regional offices on November 21, 2012 both in the United States and foreign accounts. This notice informed customers of the issue with the CLINITEK Atlas and Chek-Stix Positive Urinalysis Control Solutions 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 25C (77F). You can use the reconstituted positive control solution for up to eight hours if the solution is held at 25C (77F) or lower. If the operating temperature is greater than 25C and lower than 30C (77F and 86F), the solution can be used for up to two hours. For questions regarding this recall call 781-269-3158.
Quantity in commerce: 6466
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
Product codes and lots: Carton/Bottle Lot Number: S9093061A P9093061A S9094081A P9094081A S0097091C P0097091C S9093061A P9093061A S9094081A P9094081A S0097091C P0097091C S0100101B P0100101B S0103042A P0103042A S0103042H P0103042H S0106062A P0106062A S9101022A P9101022A S9101022B P9101022B S9105052A P9105052A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0636-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0635-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-04
Z-0636-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-04
Z-0637-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-04
Z-0638-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-04
Z-0639-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-04
Z-0640-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-04
Z-0641-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-04

Product code JJW

K943780Class INegative Control Strips for Urinalysis (Chex-Stix, Clinitek Auto 2000, Clinitex Atlas)Heraeus Kulzer, Inc. / cleared 1994-10-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)