Recall Z-0516-2009
Quantimetrix Corporation · initiated June 1, 2007
Product
Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring total cell counts in patient Synovial fluid samples performed manually using a hemocytometer. It is also an aid for identifying the crystals which may indicate a pathological condition present in the Synovial fluid. This control is used as a third party control to confirm proper functioning of the analysis by microscopic evaluation.
Codes / lots: Lot Numbers: 38050 and 38060.
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-0516-2009
- Initiated
- June 1, 2007
- Posted by FDA
- January 17, 2009
- Terminated
- February 18, 2009
- Product code
- JPK – Mixture, Hematology Quality Control
- 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-0513-2009 | Quantimetrix QuanTscopics Urine Microscopics Control. QuanTscopics is a plastic bottle…This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and… | 06/01/2007Terminated |
| 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 |