Beckman Coulter Inc Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
CX: Level 1 -M206191, Level 2-M206192, Level 3-M206193, Level 4-M206194. LX: Level 1-M301121, Level 2- M301122, Level 3- M301122, Level 4-M301124.
Products Sold
CX: Level 1 -M206191, Level 2-M206192, Level 3-M206193, Level 4-M206194. LX: Level 1-M301121, Level 2- M301122, Level 3- M301122, Level 4-M301124.
Beckman Coulter Inc is recalling Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent. due to Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.. 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
Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.
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