Recall Z-0339-05 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc
ACT diff 2 Analyzer (Automated differential cell counter)
| Date | Dec 21, 2004 (initiated Dec 3, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 2709 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990352 | COULTER AC T DIFF 2 ANALYZER Coulter Corp., Apr 1, 1999 |