RecallDepth

ACT diff 2 Analyzer (Automated differential cell counter)

This recall has been terminated (originally issued December 21, 2004).

Company
Beckman Coulter Inc.
Recall Initiated
December 3, 2004
Posted
December 21, 2004
Terminated
January 13, 2012
Recall Number
Z-0339-05
Quantity
2709
Firm Location
Brea, CA
Official Source
View on FDA website ↗

Reason for Recall

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.

Distribution

Nationwide and Canada

Lot / Code Info

All codes

Root Cause

Other

Action Taken

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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