ACT diff 2 Analyzer recallZ-0339-05 · Beckman Coulter Inc · initiated Dec 3, 2004
Terminated All recalls posted in December 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0339-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 3, 2004
- Posted by the FDA
- Dec 21, 2004
- Recalling firm
- Beckman Coulter Inc
- Quantity
- 2709
- Product code
- GKZ
- FDA submissions
- K990352
- Distribution
- Nationwide and Canada
Product description
ACT diff 2 Analyzer (Automated differential cell counter)
Code information (models, lots, serial numbers)
All codes
Other devices under the same FDA submission
1 device cleared under K990352 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- COULTER AcT diff 2Beckman Coulter, Inc. · Counter, Differential Cell25 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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