Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Reported: April 26, 2017 Initiated: March 10, 2017 #Z-1833-2017
Product Description
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Reason for Recall
Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 889 kits total (6 kits in US)
- Distribution
- 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.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C. Recalled by Beckman Coulter Inc.. Units affected: 889 kits total (6 kits in US).
Why was this product recalled? ▼
Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 26, 2017. Severity: Moderate. Recall number: Z-1833-2017.
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