Recall Z-1435-04 ยท CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Roche Diagnostics Corp.
Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1928511 (11928511216).
| Date | Sep 2, 2004 (initiated Aug 20, 2004) |
| Status | Terminated |
| Reason | Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero patient results. |
| Root cause | Other |
| Action | Consignees were mailed recall notices dated 8/20/04 and were instructed to either reduce the initial reagent bottle volume prior to use, or to request replacement product. |
| Quantity | 757non-expired kits. |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.