Recall Z-2637-2017
Beckman Coulter Inc. · initiated May 9, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Access System-Free T4 Assay, B01902E, Catalog No. 33880
Codes / lots: all lots
Reason for recall
The Access immunoassays are susceptible to biotin interference.
FDA-determined cause: Device Design
Action taken
An urgent Medial Device Recall letter dated 5/9/17 was sent to customers to inform them that Beckman Coulter is initiating a field action for Access Total T3, Access Thyroglobulin, Access Free T4, and Access GI Monitor. Beckman Coulter has determined through customer feedback and an internal investigation that the four Access immunoassays listed above are susceptible to biotin interference. During interference testing the interference occurred with samples that contained 100 ng/mL of biotin. This level of biotin is greater than the maximum biotin concentration observed in the normal healthy population. Customers are informed of the impact, action, and resolution. Customers are instructed to respond within 10 days: electronically via email or manually by completing and returning the enclosed response form. Customers with any questions regarding the notice are instructed to contact Customer Technical Support Center: From our website: http://www.beckmancoulter.com By phone: call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter representative.
Details
- Recall number
- Z-2637-2017
- Initiated
- May 9, 2017
- Terminated
- March 30, 2018
- Product code
- CEC – Radioimmunoassay, Free Thyroxine
- Quantity
- 1,154,084 units total (167,035 units in US)
- Distribution
- Algeria, Angola, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia…
- Recalling firm
- Beckman Coulter Inc., Brea, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2635-2017 Class II | Access Total T3, A34435H, Catalog No. 33830The Access immunoassays are susceptible to biotin interference. | 05/09/2017Terminated |
| Z-2636-2017 Class II | Access Thyroglobulin, A34085G, Catalog No. 33860The Access immunoassays are susceptible to biotin interference. | 05/09/2017Terminated |
| Z-2638-2017 Class II | Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687The Access immunoassays are susceptible to biotin interference. | 05/09/2017Terminated |