Recall Z-2074-2017
Beckman Coulter Inc. · initiated April 13, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Access BR Monitor, Part No. 387620
Codes / lots: 623913, 625701, 628771, 630349, 633070 and All Future Lots
Reason for recall
Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de scurit du Medicament et des produits de sant (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU).
FDA-determined cause: Other
Action taken
An urgent Medical Device Recall letter dated 4/13/17 was sent to customers following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de scurit du Medicament et des produits de sant (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU). Customers are informed of the impact and the actions to be taken. 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-2074-2017
- Initiated
- April 13, 2017
- Terminated
- June 4, 2018
- Product code
- MOI – System, Test, Immunological, Antigen, Tumor
- Quantity
- 45,278 units total (2,419 units in US)
- Distribution
- Affected geographies: Algeria, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon…
- Recalling firm
- Beckman Coulter Inc., Brea, CA