Device product
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.
Z-0171-2016
Product summary
- Event
- Event 72321
- Status
- Terminated
- Classification
- Class III
- Quantity
- 120 units
- Official record key
device-enforcement:Z-0171-2016
Official wording
Reason: Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.
Code information: Catalog Number: 349201; Lot Number 5148598 (expires 10-31-2016) Catalog Number: 340542; Lot Number 5113983 (expires 02-28-2017)
Distribution pattern: 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.
Derived failure modes
-
Labeling or packaging
label contains an error