Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control. The intended use is to validate the performance o
FDA device recall Z-0514-2009 · posted 2009-01-17 · Terminated
Recall details
- Recalling firm
- Quantimetrix Corporation
- Reason for recall
- This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JJW
- Quantity affected
- 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.
- Date initiated
- 2007-06-01
- Date posted
- 2009-01-17
- Date terminated
- 2009-02-18
- Location
- Redondo Beach, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QUANTIMETRIX URINE DIPSTICK CONTROL (K874890) | Quantimetrix Medical Industries | 1988-01-21 |