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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