Recall record at a glance
| Official record | Z-1833-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Beckman Coulter Inc. |
| Report date | Apr 26, 2017 |
| Recall initiation date | Mar 10, 2017 |
| Quantity | 889 kits total (6 kits in US) |
| Location | Brea, CA, United States |
Official product description
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Why the product was recalled
Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.
Distribution information
Worldwide Distribution - US Distribution and to the countries of : Algeria, Bangladesh, Belgium, Botswana, Croatia, Czech Republic, Denmark, Djibouti, Egypt, France, Germany, Ghana, Greece, Hungary, Ireland, Italy, Kazakhstan, Lebanon, Lithuania, Morocco, Nepal, Netherlands, Oman, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Zimbabwe.
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
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