Mikro 12-24 Centrifuge with 2050 Rotor TYP #2070 and TYP 2070-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured.
FDA Recall Z-0612-2010 · Posted 2010-01-21
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Recalling FirmHettich Instruments Management I
Recall StatusTerminated
Product CodeGKG
Date Initiated2009-11-21
Date Terminated2011-10-25
Product Quantity46 units total
Reason for Recall
Centrifuge Rotor Failure: may crack, break, and explode outside the centrifuge.
Firm Action
Hettich Instruments notified Distributors by email on 11/21/09, to the Request For Urgent Action notifications, dated 11/23/2009. There is a description of how to identify a recalled rotor as well as a description of the replacement metal rotor that is to be used in place of the list of centrifuges affected by this recall. Customers are to cease using the setup described and contact their distributor or the firm. The firm will replace the plastic housing with a metal housing. Questions should be directed to 978-232-3957.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- USA, including states of CT and IN, and country of Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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