Recall Z-0514-2009 ยท JJW Urinalysis Controls (Assayed And Unassayed)
Quantimetrix Corporation
Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control. The intended use is to validate the performance of the Multistix, Chemstrip, Uriscan, QuickVue, Diascreen and other urinalysis reagent strips, and as a control for confirmatory tests such as Acetest, Clinitest, and Icotest reagent tablets, and as a control for hCG methods. In addition, the Dip and Spin Control is intended as
| Date | Jan 17, 2009 (initiated Jun 1, 2007) |
| Status | Terminated |
| Reason | This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group. |
| Root cause | Employee error |
| Action | The recall communication was initiated when customer both direct and distributors who have purchased the lots were mailed a recall notification letter dated June 8, 2008 with instructions which was sent via first class mail. Customers were requested to assist in the voluntary recall of the listed product and if any of the affected lots have been consumed please review their records to ensure that the obtained values conform to the stated specifications found in the lot specific product insert. |
| Quantity | 24,937 sets for all products. |
| Distribution | Nationwide Distribution including states of AK, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NH, NM, NY, OR, PA, SC, SD, TN, TX, VA, WA and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K874890 | QUANTIMETRIX URINE DIPSTICK CONTROL Quantimetrix Medical Industries, Jan 21, 1988 |