Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.
- Company
- Ortho-Clinical Diagnostics
- Recall Initiated
- December 3, 2003
- Posted
- January 6, 2004
- Terminated
- February 20, 2004
- Recall Number
- Z-0299-04
- Quantity
- 524 reagent packs
- Firm Location
- Rochester, NY
Reason for Recall
Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
Distribution
154 reagent packs shipped to consignees in the U.S. 370 reagent packs shipped to Ortho/J&J International Affiliates for further distribution to foreign users. Foreign consignees are located in Argentina, Australia, Belgium, Brazil, Chile, China, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Portugal, Puerto Rico, Singapore, Spain, United Kingdom, and Venezuela.
Lot / Code Info
Lot #750, Exp. 14 January 2004
Root Cause
Other
Action Taken
U.S. customers notified via FED EX letter sent on 12/3/03. Letter includes modified QC procedures to use until replacement product is issued. Foreign affiliates notified via e-mail on 12/3/03 with instructions to notify customers.