Recall record at a glance
| Official record | Z-2979-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Beckman Coulter Biomedical GmbH |
| Report date | Sep 11, 2024 |
| Recall initiation date | Jul 17, 2024 |
| Location | Munchen, Germany |
Official product description
PE Centrifuge, REF: B36365, a component of the Power Express
Why the product 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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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