Reported Sep 25, 2013 · Terminated
DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in…
Assuramed
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Assuramed · 1810 Summit Commerce Par · Twinsburg, OH · 44087
Is this the product you have?
- DiaScreen Liquid Urine ControlsPositive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number
- D76004 (4x12 mL bottles) consists of2x12mL 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
- Lot codes and dates
- Product NumberD76004
- LotsAll Lots
- Independence Medical Catalog NumberCJD76004
- Amount recalled
- 10 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The products may have been stored at temperatures outside their required storage conditions.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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