FDAFDA · Food and drugs·Recall number Z-0640-2013
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
Published January 16, 2013 · Recall initiated: November 21, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Distributor
- Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
- Lot
- Carton/BottleLot Number: C0099091A P0099091A C0100101 H P0100101 H C0103042C P0103042C
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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