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.

Class I - Dangerous
🏥 Medical Devices Recalled: July 16, 2013 Assuramed Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Product Number: D76004; Lots: All Lots; Independence Medical Catalog Number: CJD76004
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Assuramed
Reason for Recall:
The products may have been stored at temperatures outside their required storage conditions.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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 Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2196-2013

Related Recalls

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

Jul 16, 2013 Diagnostic Equipment Nationwide View Details →

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

Jul 16, 2013 Diagnostic Equipment Nationwide View Details →