FDA Medical Device Recalls (openFDA)
Hettich Instruments Management I: Haematokrit 20 Centrifuge with 2050 Rotor TYP #2014-01 and TYP#201424-01. 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.
- Recall number
- Z-0615-2010
- Recalling firm
- Hettich Instruments Management I
- Product
- Haematokrit 20 Centrifuge with 2050 Rotor TYP #2014-01 and TYP#201424-01. 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.
- Status
- Terminated
- Initiated
- 2009-11-21
- Posted
- 2010-01-21
- Terminated
- 2011-10-25
- 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.
- Lot, serial or model codes
- Units with plastic motor housing. TYP #2014-01 and TYP#201424-01.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GKG
- Firm FEI
- 3004578971
- Firm city
- Beverly
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28