Complete FDA and NHTSA recall records dated in September 2020.
These records include useful source details for the selected month.
Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the…
Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.
May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or troubleshooting deployment method provided…
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional…
An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additional…
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false…
Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 94175452 affected by the…
The firm has received reports concerning the patient fiducial disk separating from the body and users attempting to re-assemble the device. The use of a re-assembled patient fiducial could…
Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.
Peach Salsa was made with peaches may be contaminated with Salmonella.
The recall was initiated after it was discovered that the Ancient Grain Jackfruit Bowl containing anchovies was distributed in packaging that did not reveal the presence of fish.
Trace back information in an outbreak of Salmonella Enteritidis shows peaches from Wawona as likely source of contamination.
Onions included various meal kits delivered the week of July 27, 2020 may be contaminated with Salmonella.
Lancaster Foods LLC, 7700 Conowingo Avenue, Jessup, MD 20794 is initiating a recall of products that may have been made with the 500 pounds (bulk) of red onions out of a lot of 12,000…
Onions included various meal kits delivered the week of July 27, 2020 may be contaminated with Salmonella.
Package label does not declare soy lecithin.
Undeclared black bean powder, jalapeno pepper powder, paprika, extract of paprika and disodium inosinate and disodium guanylate.
Onions included various meal kits delivered the week of July 27, 2020 may be contaminated with Salmonella.
CGMP Deviations: Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Subpotent Drug: FDA analysis found product to be subpotent
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
