Recall Z-0171-2016 ยท LIZ Assay, T Lymphocyte Surface Marker
Becton, Dickinson and Company, BD Biosciences
BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.
| Date | Sep 30, 2015 |
| Status | Terminated |
| Reason | Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text. |
| Root cause | Under Investigation by firm |
| Action | BD sent an "URGENT PRODUCT RECALL" letter dated September 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer Actions: 1. Discard all remaining stock of CD3 (SK7) FITC, catalog number 349201, lot number 5148598, and/or catalog number 340542, lot number 5113983, and request replacement product. BD will replace product at no cost. 2.As a requirement of our Regulatory Tracking Process, we request that you complete the enclosed Tracking Verification form, even if you no longer have the affected reagents |
| Quantity | 120 units |
| Distribution | US (nationwide) Distribution to the states of : TX, GA, IN, TN, CA, KY, WA, IL, MO, NY, CT, MN, NV, KS, WI, NH, FL, PA, OH, OR, SC. OK, NC and LA., and Internationally to Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842218 | ANTI-LEU-4 FITC LYSIN C BUFFER Bd Becton Dickinson Vacutainer Systems Preanalytic, Dec 27, 1984 |