Beckman Coulter Inc IMMAGE IGMLC Reagent Part Number: 447470 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMMAGE IGMLC Reagent Part Number: 447470
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Lots prior to M303157
Products Sold
Lots prior to M303157
Beckman Coulter Inc is recalling IMMAGE IGMLC Reagent Part Number: 447470 due to Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).. 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
Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).
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