Recall Z-1564-2022— bioMerieux, Inc.

Class II · Ongoing

Class II FDA medical device recall by bioMerieux, Inc., initiated 2022-07-20. FDA's recall record names no specific 510(k) clearance for this event. Product: NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.. Reason: There is a potential of no result leading to possible delayed result due to contamination of extraction reagents..

Recalling firm
bioMerieux, Inc.
Classification
Class II
Status
Ongoing
Initiated
2022-07-20
Firm location
Durham, NC, United States

Product description

NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.

Reason for recall

There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.

Data sourced from openFDA. This site is unofficial and independent of the FDA.