Recall Z-2196-2013
Assuramed · initiated July 16, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Product Number: D76004; Lots: All Lots; Independence Medical Catalog Number: CJD76004
Reason for recall
The products may have been stored at temperatures outside their required storage conditions.
FDA-determined cause: Storage
Action taken
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.
Details
- Recall number
- Z-2196-2013
- Initiated
- July 16, 2013
- Posted by FDA
- September 13, 2013
- Terminated
- December 27, 2017
- Product code
- JJW – Urinalysis Controls (Assayed And Unassayed)
- Quantity
- 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.
- Recalling firm
- Assuramed, Twinsburg, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2197-2013 Class II | Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides…The products may have been stored at temperatures outside their required storage conditions. | 07/16/2013Terminated |
| Z-2198-2013 Class II | ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the…The products may have been stored at temperatures outside their required storage conditions. | 07/16/2013Terminated |