Z-2196-2013Class II

DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks...

Name: Z-2196-2013 DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks...
Creator: Assuramed
Published: 2013-07-16
License: https://open.fda.gov/license/

Assuramed / initiated 2013-07-16 / Terminated

FDA source

Assuramed began a recall of DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004... on 2013-07-16. FDA classified it as Class II and gives the reason as "The products may have been stored at temperatures outside their required storage conditions". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2196-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-16
Posted: 2013-09-13
Terminated: 2017-12-27
Recalling firm: Assuramed
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.
Product code: JJW Urinalysis Controls (Assayed And Unassayed)
Reason for recall: The products may have been stored at temperatures outside their required storage conditions.
FDA root cause: Storage
Action: Independence Medical (im) sent an Urgent Product Recall letter dated July 16, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to identify and immediately cease the distribution of the recalled products, quarantine the recalled products, and contact the recalling firm at 800-860-8027 for instructions on how to return the recalled products. Consignees who further distributed the recalled products were requested to notify their customers of the recall. Consignees were also instructed to complete the Product Recall Acknowledgement Form and return the document by email to [email protected] indicating receipt of the notification.Customers with questions were instructed to contact the product manufacturer for ProTime Disposable Cuvettes at 800-579-2255, DiaScreen Liquid Urine Controls at 800-818-8877, and Hemoccult II SENSA elite Dispensapak at 800-854-3633. For questions regarding this recall call 800-860-8027.
Quantity in commerce: 10 units
Distribution: Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.
Product codes and lots: Product Number: D76004; Lots: All Lots; Independence Medical Catalog Number: CJD76004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2196-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2196-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-13
Z-2197-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-13
Z-2198-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-13

Product code JJW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)