RecallDepth

IMMAGE IgM Reagent Part No.: 447610

This recall has been terminated (originally issued July 23, 2004).

Company
Beckman Coulter Inc.
Recall Initiated
June 6, 2003
Posted
July 23, 2004
Terminated
August 30, 2004
Recall Number
Z-1150-04
Quantity
10,000
Firm Location
Brea, CA
Official Source
View on FDA website ↗

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.

Lot / Code Info

Lots M210213, M303183

Root Cause

Other

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