Recall Z-0298-04 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
Ortho-Clinical Diagnostics
Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.
| Date | Jan 6, 2004 (initiated Nov 26, 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 | Customers notified via phone and faxed letter on 11/26/03. Customers provided with a modified QC procedure to be used until new shipments can be made. |
| Quantity | 774 reagent packs |
| Distribution | 738 reagent packs shipped to U.S. consignees and 36 reagent packs to Canadian consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993068 | VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS Ortho-Clinical Diagnostics, Oct 4, 1999 |