Reported Aug 3, 2016 · Terminated
Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA.…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593
- Product LabelingIFU B29071AA
- Product UsageFor 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
- Lot codes and dates
AFB13H005AFB13H008AFB13H012AFB13K002AFB13K005AFB13K008AFB13J002AFB13J003AFB13J004AFB13J005AFB13J007AFB15J001AFB15C010AFB13K009AFB14H001AFB15C008AFB15C003AFB15C005AFB15C004AFB15C006AFB14H005AFB14H003AFB13K004AFB13K006AFB13K007AFB13J008AFB13K001AFB13J006AFB13J010AFB13H013AFB13H009AFB13H003AFB13H004
- Amount recalled
- 62 units total (33 units in US)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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