Firm-initiated recall ongoing. Package insert bears the complete statement. Anti-Fyb Blood Grouping Reagent. Firm-initiated recall complete. Firm-initiated recall ongoing.
Firm estimates none remains on the market.
FDA approved the firm's corrective action plan November 29, 1993. Firm-initiated field correction ongoing. Firm-initiated field correction ongoing. The frequency and significance of changes to the radiation and treatment planning system software suggest an inadequate validation of the software system. FDA approved the firm's corrective action plan November 20, 1993.