Recall Z-2197-2013 ยท KHE Reagent, Occult Blood
Assuramed
Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and enhancer in an aqueous solution; Applicator Sticks; Patient Screening Kit Dispensing Envelopes with Patient Instructions; Flu
| 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 | 13 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
| K080812 | HEMOCCULT ICT Beckman Coulter, Inc., Jun 25, 2008 |