Microbiologics Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use recall — FDA Z-0982-2019
Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.
Complete FDA and NHTSA recall records dated in March 2019.
These records include useful source details for the selected month.
Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.
The swivel arm holding the monitors may become dislodged from the carrying arm.
The swivel arm holding the monitors may become dislodged from the carrying arm.
The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose…
The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain…
Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE…
Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance criteria for…
The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain…
During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides targets of the BD…
The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended…
Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain…
The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain…
The product was potentially being packaged without a taper adapter.
The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose…
Cheese pizza may contain plastic pieces.
A food contact surface at the firm's supplier facility tested positive for Listeria monocytogenes. Product packed on this table was shipped to Southern Specialties.
Hot Smoked Salmon products are recalled due to a potential to be contaminated with Clostridium botulinum. Certain lots of products were found to be below 3.5% water-phase salt (WPS) content.
21st Century HealthCare, Inc. is recalling Good Neighbor Pharmacy brand Co Q10 200mg 30ct capsules due the product being mislabeled and potentially containing Vit D 2000 IU.
A food contact surface at the firm's supplier facility tested positive for Listeria monocytogenes. Product packed on this table was shipped to Southern Specialties.
Cold Pressed Juice Watermelon WTRMLN WTR Original 12 packs due to the potential presence of soft plastic that may be loosely floating in some of the finished products.
21st Century HealthCare, Inc. is recalling Good Neighbor Pharmacy brand Co Q10 200mg 30ct capsules due the product being mislabeled and potentially containing Vit D 2000 IU.
A food contact surface at the firm's supplier facility tested positive for Listeria monocytogenes. Product packed on this table was shipped to Southern Specialties.
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.