Recall Z-2196-2013 ยท JJW Urinalysis Controls (Assayed And Unassayed)
Assuramed
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 dipst
| Date | Sep 13, 2013 (initiated Jul 16, 2013) |
| Status | Terminated |
| Reason | The products may have been stored at temperatures outside their required storage conditions. |
| 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 c |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.