PE Centrifuge, REF: B36365, a component of the Power Express recallZ-2979-2024 · Beckman Coulter Biomedical GmbH · initiated Jul 17, 2024
Class II Open, Classified All recalls posted in September 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter Biomedical GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2979-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jul 17, 2024
- Posted by the FDA
- Sep 5, 2024
- Recalling firm
- Beckman Coulter Biomedical GmbH
- Product code
- CDD
- FDA submissions
- K140496
- 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 description
PE Centrifuge, REF: B36365, a component of the Power Express
Code information (models, lots, serial numbers)
UDI: (01)15099590673550/ All serial numbers Lots
Other devices under the same FDA submission
1 device cleared under K140496 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Power ExpressBeckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 95064).
- Z-2978-2024 · Open, ClassifiedPower Express, REF B90918
- Z-2980-2024 · Open, ClassifiedPE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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