FDA (Devices) recall action 89401
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
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.
Diagnostic control microorganisms manufactured by Microbiologics Inc are recalled for returning incorrect antibiotic susceptibility test results. These controls failed quality specifications and could cause inaccurate lab test results.
Microbiologics Inc recalls KWIK-STIK AST-GP quality control materials that produce incorrect antibiotic susceptibility test results. Two lot numbers were distributed worldwide.
Microbiologics recalls KWIK-STIK blood culture identification quality control panels due to incorrect susceptibility test results. High-level Gentamicin Synergy values were out of specification, risking inaccurate diagnostic guidance.
Microbiologics Inc is recalling KWIK-STIK quality control kits used by laboratories because certain lots return incorrect test results that could affect laboratory testing accuracy.
Microbiologics Inc is recalling 139 units of KWIK-STIK AST-GP QC microorganism sets due to incorrect susceptibility test results. The products failed gentamicin synergy specifications and could affect the accuracy of laboratory diagnostic testing.