Recall Z-3119-2017 ยท JJH Clinical Sample Concentrator
bioMerieux, Inc.
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).
| Date | Apr 10, 2017 |
| Status | Terminated |
| Reason | Some anomalies have been identified during manufacturing controls. |
| Root cause | Unknown/Undetermined by firm |
| Action | 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 ch |
| Quantity | 15 US |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.