FDAFDA · Food and drugs·Recall number Z-2196-2013
DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.; Minneapolis, MN 55439 Diascreen liquid urine control is a synthetic control designed to react with commercial urine dipsticks to register listed responses on color reagent pads. It is intended for use in a clinical laboratory as a urine control for qualitative procedures used in chemical determinations. The control is intended to be used exactly as if it were a patient sample to assist in the assessment of the listed analytical procedures.
Published September 25, 2013 · Recall initiated: July 16, 2013
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
The products may have been stored at temperatures outside their required storage conditions.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Assuramed
- Distributor
- Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.
- Lot
- Product Number: D76004; Lots: All Lots; Independence Medical Catalog Number: CJD76004
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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