Z-1146-04

IMMAGE IGALC Reagent Part Number: 447460

Name: Z-1146-04 IMMAGE IGALC Reagent Part Number: 447460
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 IGALC Reagent Part Number: 447460 on 2003-06-06. The reason FDA records is "Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1146-04
Status: Terminated
Initiated: 2003-06-06
Posted: 2004-07-23
Terminated: 2004-08-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMAGE IGALC Reagent Part Number: 447460
Product code: CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Reason for recall: Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).
FDA root cause: Other
Product codes and lots: Lots prior to M303259

Product code CFN

K993547Class IIBeckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc) Reagent, Beckman Coulter CerebBeckman Coulter, Inc. / cleared 2000-02-01

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)