FDA (Devices) recall action 91075
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.
Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.
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.
Accelerate Diagnostics is recalling 200 kits of the Accelerate PhenoTest BC diagnostic test due to improperly formulated FISH probes that may produce false positive results for Staphylococcus aureus and Streptococcus bacteria.
Accelerate Diagnostics is recalling the Accelerate PhenoTest BC kit due to improperly formulated FISH probes that produce false positive identification results for Staphylococcus aureus and Streptococcus species. Approximately 7,160 kits have been distributed across the United States and internationally.