FDA (Devices) recall action 94024
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.
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes .
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.
Mckesson Medical-Surgical is recalling Steris Endo Cleaning Indicator VERIFY RESITEST devices due to temperature excursions that occurred on January 8, 2024. The temperature drop could cause the indicator to produce incorrect or delayed test results.
A Sekisui Diagnostics control kit for bacterial vaginosis testing was recalled after exposure to temperatures below the validated storage range for up to 60 minutes due to refrigerator mechanical failure.
Abbott's i-STAT Level 1 control device is recalled because a refrigerator temperature excursion on January 8, 2024, could cause incorrect or delayed test results. The walk-in storage unit failed, causing temperatures to fall below the required range of 35.6-46.4°F.
McKesson recalls Abbott Rapid Dx pregnancy test control sets due to a refrigerator temperature excursion that could cause inaccurate or delayed test results.
Abbott Point of Care Control i-STAT Level 3 control material (Lot 121164) is being recalled due to temperature excursions in storage that could affect test accuracy. Affected units were distributed in Arizona, Pennsylvania, and Texas.