eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristics or after pre-treatment).
Recall
- Recall Number
- Z-3119-2017
- Event Number
- 77989
- Firm
- bioMerieux, Inc.
- FEI Number
- 3002769706
- Product Code
- JJH
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- April 10, 2017
- Terminated
- February 24, 2022
- Address
- 100 Rodolphe St, Durham, NC, 27712-9402
Description
eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristics or after pre-treatment).
Some anomalies have been identified during manufacturing controls.
The firm, Biomerieux, sent an "IMPORTANT: URGENT PRODUCT SAFETY CORRECTION NOTICE" letter on 4/10/2017 to its Consignees. The letter described the product, problem and actions to be taken. The Consignees were instructed to distribute this information to all appropriate personnel; retain copy for files; forward information to all parties that may use this product; perform a Main Board Re-initialization after each weekly maintenance; and complete and return the Acknowledgment Form by Fax to + 33 (0) 04 78 87 73 07 to confirm receipt of notice. A Field Service engineer will come on site to check the unit. If you require additional assistance or have any questions, please contact your local bioMrieux Customer Service representative or call 919-620-3396 or email: [email protected].
Worldwide Distribution: US (nationwide) to states of: GA, IL, IN, MA, NC & TX and to countries of: Austria, France, Germany, Hong Kong, Italy, Netherlands, Spain, Sweden, Switzerland, Thailand and United Kingdom.
15 US