Recall Z-0299-04 ยท DHX System, Test, Carcinoembryonic Antigen
Ortho-Clinical Diagnostics
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.
| Date | Jan 6, 2004 (initiated Dec 3, 2003) |
| Status | Terminated |
| Reason | Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results. |
| Root cause | Other |
| Action | 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. |
| Quantity | 524 reagent packs |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.