FDA Recall
Terminated
CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 ****
Recall: Z-0557-03
·
Initiated December 18, 2002
Recall
- Recall Number
- Z-0557-03
- Event Number
- 25319
- Firm
- Ortho-Clinical Diagnostics
- FEI Number
- 1000136573
- Status
- Terminated
- Root Cause
- Other
- Initiated
- December 18, 2002
- Posted
- February 21, 2003
- Terminated
- April 14, 2003
- Address
- 100 Indigo Creek Drive, Rochester, NY, 14650-0881
Description
CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 ****
Reason
Cartons labeled 'TDM Performance Verifier I' may contain TDM Performance Verified II.
Action
Letters dated 12/18/02 with instructions to inspect inventory and to discard affected product.
Distribution
Nationwide distribution to medical facilities, distributors, and U.S. government consignees (39).
Quantity
1,338 cartons