Professional Urine Drug Control — Class II medical device recall Z-2050-2020
Terminated recall by Cardinal Health Inc., reported 2020-05-27, distributed nationwide. Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperatu
| Recall number | Z-2050-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health Inc., Dublin, OH, United States |
| Recall initiated | 2020-04-20 |
| Classified | 2020-05-20 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2020-07-23 |
| Distributed | Nationwide (US) |
| Reason classes | temperature control |
| Lot numbers | KN00146 |
| Model numbers | 88010 |
Product
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 detect the control constituents.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2050-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.