Beckman Coulter Inc IMMAGE IgM Reagent Part No.: 447610 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMMAGE IgM Reagent Part No.: 447610
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Lots M210213, M303183
Products Sold
Lots M210213, M303183
Beckman Coulter Inc is recalling IMMAGE IgM Reagent Part No.: 447610 due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: distribution information, corrective action details.
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026