ACT diff 2 Analyzer (Automated differential cell counter)
FDA device recall Z-0339-05 · posted 2004-12-21 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 2709
- Distribution
- Nationwide and Canada
- Date initiated
- 2004-12-03
- Date posted
- 2004-12-21
- Date terminated
- 2012-01-13
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COULTER AC T DIFF 2 ANALYZER (K990352) | Coulter Corp. | 1999-04-01 |