Beckman Coulter Inc Synchron Systems Prealbumin Reagent Part Number: 475106 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Synchron Systems Prealbumin Reagent Part Number: 475106
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Lot M210125 Exp 30 Nov 04
Products Sold
Lot M210125 Exp 30 Nov 04
Beckman Coulter Inc is recalling Synchron Systems Prealbumin Reagent Part Number: 475106 due to Instability leading to falsely elevated patient results, out of range controls, or error code.. 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
Instability leading to falsely elevated patient results, out of range controls, or error code.
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