FDA Device

ACT diff 2 Analyzer (Automated differential cell counter)

Hazard

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.

What You Should Do

Remedy

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.

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Products

ACT diff 2 Analyzer (Automated differential cell counter)
Brand
Beckman Coulter Inc
UPC
All codes

Units Affected

2709

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