FDA (Devices) recall action 78688
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
BioMerieux SA is recalling ETEST Oxacillin strips due to quality control failures that may cause false resistant results.
BioMerieux SA is recalling ETEST OXACILLIN OX 256 WW F100 in vitro diagnostic strips due to quality control failures that may cause false resistant results.