Z-2979-2024Class II

PE Centrifuge, REF: B36365, a component of the Power Express

Name: Z-2979-2024 PE Centrifuge, REF: B36365, a component of the Power Express
Creator: Beckman Coulter Biomedical GmbH
Published: 2024-07-17
License: https://open.fda.gov/license/

Beckman Coulter Biomedical GmbH / initiated 2024-07-17 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter Biomedical GmbH began a recall of PE Centrifuge, REF: B36365, a component of the Power Express on 2024-07-17. FDA classified it as Class II and gives the reason as "The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2979-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-17
Posted: 2024-09-05
Recalling firm: Beckman Coulter Biomedical GmbH
Product: PE Centrifuge, REF: B36365, a component of the Power Express
Product code: CDD Radioassay, Vitamin B12
Reason for recall: The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On July 18, 2024, Beckman Coulter issued a "Urgent Medical Device Recall" notification to affected consignees. Beckman Coulter asked consignees to take the following actions: 1. follow your laboratory procedure to handle biohazard materials and contact your Beckman Coulter representative for servicing your Power Express system. 2. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected products listed above to another laboratory, please provide them a copy of this letter. 3. respond within 10 days in one of the following ways: . Electronically, if you received this communication via email. . Manually, complete and return the enclosed Response Form. 4. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Bahrain, Canada, China, Colombia, Egypt, France, Germany, Italy, Jordan, Korea, Kuwait, Lebanon, Malaysia, Panama, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, United Arab Amirates, United Kingdom, Vietnam.
Product codes and lots: UDI: (01)15099590673550/ All serial numbers Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2979-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2978-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-05
Z-2979-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-05
Z-2980-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-05

Product code CDD

K140496Class IIAccess Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System ReagentsBeckman Coulter, Inc. / cleared 2014-09-16

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)