NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with t
FDA device recall Z-2342-2016 · posted 2016-08-09 · Terminated
Recall details
- Recalling firm
- BioMerieux SA
- Reason for recall
- Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.
- Action taken
- Consignees were notified of the recall by letter on July 18, 2016. The letter informed them of what actions need to be taken if they experience problems. The letter included a reply form to be returned. Subsidiaries and distributors were notified electronically on 7/8/2016.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- LDT
- Quantity affected
- 7,845 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA,
- Date initiated
- 2016-07-08
- Date posted
- 2016-08-09
- Date terminated
- 2022-03-10
- Location
- Marcy L'Etoile, France
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