IMMAGE IgM Reagent Part No.: 447610
FDA Recall Z-1150-04 · Posted 2004-07-23
Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeDEW
Date Initiated2003-06-06
Date Terminated2004-08-30
Product Quantity10,000
Reason for Recall
low level IgM serum sample results may be suppressed and an error code generated when using affected lots. Error codes are seen as E60 or E66.
Root Cause
Other
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.