FDA Device recall Z-2196-2013
DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis by Assuramed, citing the products may have been stored at temperatures outside their required storage conditions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2196-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-16 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Assuramed |
| Distribution | US |
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
The products may have been stored at temperatures outside their required storage conditions.
Identifiers
| code_info | Product Number: D76004; Lots: All Lots; Independence Medical Catalog Number: CJD76004 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2196-2013%22
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