FDA (Devices) recall action 96752
The FDA (Devices) publishes a recall like this one as 32 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 32 pages.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
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.
HemoCue Inc Hemotrol Low Level 1 control product was subject to transit delays during severe thunderstorms that may have caused storage outside recommended temperature conditions, potentially leading to incorrect or delayed test results.
McKesso Medical-Surgical Inc. is recalling Ortho Clinical Diagnostics FS Diluent Packs due to transit delays from severe thunderstorms that may have caused improper storage conditions. The affected products could produce incorrect or delayed test results.
Abbott Diagnostics ARC T-Uptake Assay reagent is being recalled because severe thunderstorms caused certain units to be stored outside recommended temperature conditions, which may result in incorrect or delayed test results.
Ortho Clinical Diagnostics Vitros Calcium (L-Sequester) reagent is being recalled because transit delays caused by severe thunderstorms may have stored products outside recommended cold chain conditions, potentially leading to incorrect or delayed test results.
Abbott Diagnostics ARCH AUSAB Anti-HBS reagent units may have been stored outside recommended temperature conditions due to transit delays caused by severe thunderstorms, potentially leading to incorrect or delayed test results.
Abbott Diagnostics Architect Progesterone (100 tests) reagent is being recalled due to transit delays during severe thunderstorms that may have caused storage outside recommended conditions, risking incorrect or delayed test results.
Abbott Rapid DX Cholestec LDX Lipid Profile test cassettes are being recalled because transit delays caused by severe thunderstorms may have exposed products to storage temperatures outside recommended conditions, which could result in incorrect or delayed test results.