Z-2274-2016Class II

Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU...

Name: Z-2274-2016 Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU...
Creator: Beckman Coulter Inc.
Published: 2016-02-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-02-05 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro Diagnostic Use... on 2016-02-05. FDA classified it as Class II and gives the reason as "A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced configuration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2274-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-05
Posted: 2016-07-23
Terminated: 2017-01-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is designed to separate human samples, including blood and other body fluids, for processing, analysis and in vitro diagnostic testing, as well as non-human body samples and chemicals, including industrial and environmental samples. This centrifuge should be operated by qualified personnel only.
Product code: JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Reason for recall: A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced configuration.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Beckman Coulter sent an Important Product Notice Recall letter dated February 5, 2016 to customer. The letter identified the affected product problem and actions to be taken. Customers are instructed to complete and return the enclosed Response Form. Customers with questions are instructed to contact our Customer Support Center " Via website, http://www.beckmancoulter.com/customersupport/support " Via phone, call 800-369-0333 the United States and Canada " Outside the United States and Canada, contact your local Beckman Coulter Representative.
Quantity in commerce: 62 units total (33 units in US)
Distribution: Worldwide Distribution - US Nationwide (including Puerto Rico) and the countries of: Australia, Canada, Colombia, Germany, Guatemala, Netherlands, Singapore, Tunisia, , Spain
Product codes and lots: AFB13H005, AFB13H008, AFB13H012, AFB13K002, AFB13K005, AFB13K008, AFB13J002, AFB13J003, AFB13J004, AFB13J005, AFB13J007, AFB15J001, AFB15C010, AFB13K009, AFB14H001, AFB15C008, AFB15C003, AFB15C005, AFB15C004, AFB15C006, AFB14H005, AFB14H003, AFB13K004, AFB13K006, AFB13K007, AFB13J008, AFB13K001, AFB13J006, AFB13J010, AFB13H013, AFB13H009, AFB13H003, AFB13H004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2274-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2274-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-22

Product code JQC

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)