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U.S. Department of Health and Human Services

Class 2 Device Recall DiaScreen Liquid Urine Controls

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  Class 2 Device Recall DiaScreen Liquid Urine Controls see related information
Date Initiated by Firm July 16, 2013
Date Posted September 13, 2013
Recall Status1 Terminated 3 on December 27, 2017
Recall Number Z-2196-2013
Recall Event ID 65980
Product Classification Urinalysis controls (assayed and unassayed) - Product Code JJW
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.
Code Information Product Number: D76004;  Lots: All Lots;  Independence Medical Catalog Number: CJD76004
Recalling Firm/
Manufacturer		 Assuramed
1810 Summit Commerce Par
K
Twinsburg OH 44087
Manufacturer Reason
for Recall		 The products may have been stored at temperatures outside their required storage conditions.
FDA Determined
Cause 2		 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 recall@indemed.com 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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