Recalls / —
—#158456
Product
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).
- FDA product code
- JJH — Clinical Sample Concentrator
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- Serial Numbers - IM03001, IM03002, IM3004, IM03005, IM03006, IM03007, IM03008, IM03009, IM03011, IM03012, IM03013, IM03014, IM03015, IM03017, IM03019
Why it was recalled
Some anomalies have been identified during manufacturing controls.
Root cause (FDA determination)
Unknown/Undetermined by firm
Action the firm took
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: tiffiany.mentzel@biomerieux.com.
Recalling firm
- Firm
- bioMerieux, Inc.
- Address
- 100 Rodolphe St, Durham, North Carolina 27712-9402
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2017-04-10
- Terminated
- 2022-02-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #158456. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.