Z-0614-2010

Mikro 20 Centrifuge with 2076 Rotor TYP #2004 and TYP #2004-01. Used for the purpose of determining the...

Name: Z-0614-2010 Mikro 20 Centrifuge with 2076 Rotor TYP #2004 and TYP #2004-01. Used for the purpose of determining the...
Creator: Hettich Instruments Management I
Published: 2009-11-21
License: https://open.fda.gov/license/

Hettich Instruments LP / initiated 2009-11-21 / Terminated / root cause: design

FDA source

Hettich Instruments Management I began a recall of Mikro 20 Centrifuge with 2076 Rotor TYP #2004 and TYP #2004-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying... on 2009-11-21. The reason FDA records is "Centrifuge Rotor Failure: may crack, break, and explode outside the centrifuge". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0614-2010
Status: Terminated
Initiated: 2009-11-21
Posted: 2010-01-21
Terminated: 2011-10-25
Recalling firm: Hettich Instruments LP
Product: Mikro 20 Centrifuge with 2076 Rotor TYP #2004 and TYP #2004-01. 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.
Product code: GKG Centrifuge, Hematocrit
Reason for recall: Centrifuge Rotor Failure: may crack, break, and explode outside the centrifuge.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 46 units total
Distribution: Worldwide Distribution -- USA, including states of CT and IN, and country of Canada.
Product codes and lots: Units with plastic motor housing. TYP #2004 and TYP #2004-01.

Product code GKG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)