Beckman Coulter Inc ACT diff 2 Analyzer (Automated differential cell counter) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACT diff 2 Analyzer (Automated differential cell counter)
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
All codes
Products Sold
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Beckman Coulter Inc is recalling ACT diff 2 Analyzer (Automated differential cell counter) due to Erroneous results issue when MONOJECT blood collection tubes are used during analysis after tubes are uncapped and recapped then analysed in the close. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Erroneous results issue when MONOJECT blood collection tubes are used during analysis after tubes are uncapped and recapped then analysed in the closed vial mode. Results are lower than if cap had not been removed.
Recommended Action
Per FDA guidance
A letter issued to users informing them of the incompatability of the Coulter ACT diff 2 Analyzer with the use of Monoject blood collection tubes made by Tyco Healthcare Group/Kendall Healthcare. Customers choosing to use these tubes are instructed to uncap the tubes and analyze the samples,as open vial samples.
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