Recall Z-0513-2009
Quantimetrix Corporation · initiated June 1, 2007
Product
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.
Codes / lots: Lot Number: 48170, 48171, 48172, 48180, 48181 and 48182.
Reason for recall
This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-0513-2009
- Initiated
- June 1, 2007
- Posted by FDA
- January 17, 2009
- Terminated
- February 18, 2009
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- 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.
- Recalling firm
- Quantimetrix Corporation, Redondo Beach, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0514-2009 | Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control. The intended use…This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and… | 06/01/2007Terminated |
| Z-0515-2009 | Quantimetrix SpinalScopics Spinal Fluid Cell Count Control. Spinalscopics is a plastic…This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and… | 06/01/2007Terminated |
| Z-0516-2009 | Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic bottle…This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and… | 06/01/2007Terminated |