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U.S. Department of Health and Human Services

Class 3 Device Recall Siemens ChekStix Combo Pak

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 Class 3 Device Recall Siemens ChekStix Combo Pak see related information
Date Posted January 04, 2013
Recall Status1 Terminated on November 06, 2014
Recall Number Z-0637-2013
Recall Event ID 63809
510(K)Number K943780 
Product Classification Urinalysis controls (assayed and unassayed) - Product Code JJW
Product Siemens Chek-Stix Combo Pak
Catalog Number: 1364

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
Code Information Carton/Bottle Lot Number:
C9093061C P9093061C
C9094081J P9094081J
C0100101D P0100101D
C0097091E P0097091E
C9101022E P9101022E
C0099091D P0099091D
C0100101E P0100101E
C9101022H P9101022H
C9101022J P9101022J
C0103042B P0103042B
C0103042G P0103042G
C0106062D P0106062D
C9105052C P9105052C
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
508-359-3877
For Additional Information Contact Mark Smith
781-269-3158
Manufacturer 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).
FDA Determined
Cause 2
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 25¿C (77¿F). You can use the reconstituted positive control solution for up to eight hours if the solution is held at 25¿C (77¿F) or lower. If the operating temperature is greater than 25¿C and lower than 30¿C (77¿F and 86¿F), the solution can be used for up to two hours. For questions regarding this recall call 781-269-3158.
Quantity in Commerce 16711
Distribution Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJW and Original Applicant = HERAEUS KULZER, INC.
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