Beckman Coulter Inc Synchron Systems Hemoglobin A1c (HbA1c) Reagent Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Synchron Systems Hemoglobin A1c (HbA1c) Reagent
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Part 650252 Product Lot Numbers: M206003 M209057
Products Sold
Part 650252 Product Lot Numbers: M206003 M209057
Beckman Coulter Inc is recalling Synchron Systems Hemoglobin A1c (HbA1c) Reagent due to Results of tests are biased low due to a vendor change in formulation not brought to the attention of the recalling firm.. 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
Results of tests are biased low due to a vendor change in formulation not brought to the attention of the recalling firm.
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