CLASS II ONGOING Device recall · Reported 11 Sep 2024 · FDA Enforcement Report
PE Centrifuge recalled by Beckman Coulter Biomedical
Beckman Coulter Biomedical is recalling PE Centrifuge, distributed nationwide in the US. The recall was initiated on 17 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2979-2024
- FDA event ID
- 95064
- Recalling firm
- Beckman Coulter Biomedical, Munchen
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jul 2024
- FDA classified
- 5 Sep 2024
- Reported
- 11 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 17 Jul 2024 | Recall initiated by company | |
| 5 Sep 2024 | Classified by FDA | +50 days |
| 11 Sep 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
PE Centrifuge, REF: B36365, a component of the Power Express
Where it was distributed
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.
Questions about this recall
Why was it 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.
Which lots are affected?
UDI: (01)15099590673550/ All serial numbers Lots
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 95064This product is part of a recall event; the main page for the event is PE Centrifuge Temperature Controlled recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | PE Centrifuge Temperature Controlled recalled | Beckman Coulter Biomedical | Foreign Material | Nationwide | |
| CLASS II | Power Express recalled by Beckman Coulter Biomedical | Beckman Coulter Biomedical | Foreign Material | Nationwide |
More recalls from Beckman Coulter Biomedical
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Remisol Advance recalled by Beckman Coulter Biomedical | Beckman Coulter Biomedical | Potency & Assay | 5 states |
| Device | CLASS II | Power Express recalled by Beckman Coulter Biomedical | Beckman Coulter Biomedical | Foreign Material | Nationwide |
| Device | CLASS II | PE Centrifuge Temperature Controlled recalled | Beckman Coulter Biomedical | Foreign Material | Nationwide |
| Device | CLASS II | Beckman Coulter DxA Automation System, DxA recalled | Beckman Coulter Biomedical | Device Malfunction | 17 states |
| Device | CLASS II | Beckman Coulter DxA Automation System, DxA 5000 Fit recalled | Beckman Coulter Biomedical | Device Malfunction | 17 states |
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