Z-0640-2013Class II

Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix Positive and Negative...

Name: Z-0640-2013 Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix Positive and Negative...
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 Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with... 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-0640-2013
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 Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
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: 1130
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/BottleLot Number: C0099091A P0099091A C0100101 H P0100101 H C0103042C P0103042C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0640-2013
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)