Recall Z-2196-2013— Assuramed

Class II FDA medical device recall by Assuramed, initiated 2013-07-16, terminated 2017-12-27. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: The products may have been stored at temperatures outside their required storage conditions..

Recalling firm

Assuramed

Classification

Class II

Status

Terminated

Initiated

2013-07-16

Terminated

2017-12-27

Firm location

Twinsburg, OH, United States

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