[Recalled] Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to d

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Cardinal Health Inc.

• Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD — Class II
• Kangaroo 924 Safety Screw Spike Set, Product Code 775759 — Class II
• OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326 — Class II
• ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862 — Class II
• FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877 — Class II
• Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100 — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.