DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid… — Class II medical device recall Z-2196-2013
Terminated recall by Assuramed, reported 2013-09-25, distributed nationwide. The products may have been stored at temperatures outside their required storage conditions.
| Recall number | Z-2196-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Assuramed, Twinsburg, OH, United States |
| Recall initiated | 2013-07-16 |
| Classified | 2013-09-13 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2017-12-27 |
| Distributed | Nationwide (US) |
| Quantity | 10 units |
| Model numbers | CJD76004 |
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 for recall
The products may have been stored at temperatures outside their required storage conditions.
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-2196-2013. 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.