Recall Z-0613-2010 ยท GKG Centrifuge, Hematocrit
Hettich Instruments Management I
Haematokrit 24 Centrifuge with 2050 Rotor TYP #2075 and TYP #2075-01. 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.
| Date | Jan 21, 2010 (initiated Nov 21, 2009) |
| Status | Terminated |
| Reason | Centrifuge Rotor Failure: may crack, break, and explode outside the centrifuge. |
| 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 | 46 units total |
| Distribution | Worldwide Distribution -- USA, including states of CT and IN, and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.