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Terminated

ACT diff 2 Analyzer (Automated differential cell counter)

FDA Recall Z-0339-05 · Posted 2004-12-21

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2004-12-03
Date Terminated2012-01-13
Product Quantity2709

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990352COULTER AC T DIFF 2 ANALYZERCoulter Corp. · 1999-04-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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