Recall Z-0513-2009 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Quantimetrix Corporation
Quantimetrix QuanTscopics Urine Microscopics Control. QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is a bi-level control with stabilized human blood cells provide a means to validate the processing and is centrifugation of urine prior to microscopic analysis in compliance with CLIA regulations.
| 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
| K925256 | QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL Quantimetrix Corp., Mar 1, 1993 |