Assuramed: Medical Device Recall in 2013 - (Recall #: Z-2196-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 16, 2013

Date Posted: September 25, 2013

Recall Number: Z-2196-2013

Event ID: 65980

Reason for Recall:

The products may have been stored at temperatures outside their required storage conditions.

Status: Terminated

Product Quantity: 10 units

Code Information:

Product Number: D76004; Lots: All Lots; Independence Medical Catalog Number: CJD76004

Distribution Pattern:

Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated