Z-1150-04

IMMAGE IgM Reagent Part No.: 447610

Name: Z-1150-04 IMMAGE IgM Reagent Part No.: 447610
Creator: Beckman Coulter Inc
Published: 2003-06-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-06-06 / Terminated

FDA source

Beckman Coulter Inc began a recall of IMMAGE IgM Reagent Part No.: 447610 on 2003-06-06. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1150-04
Status: Terminated
Initiated: 2003-06-06
Posted: 2004-07-23
Terminated: 2004-08-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMAGE IgM Reagent Part No.: 447610
Product code: DEW Igg, Antigen, Antiserum, Control
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.
FDA root cause: Other
Quantity in commerce: 10,000
Product codes and lots: Lots M210213, M303183

Product code DEW

K963868Class IIImmage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm)Beckman Instruments, Inc. / cleared 1997-02-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)