FDAFDA · Food and drugs·Recall number Z-0636-2013
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.
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/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
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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