Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells recall — FDA Z-0829-2020
Homocysteine Assay May Cause Elevated Results in the Folate Assay
Complete FDA and NHTSA recall records dated in January 2020.
These records include useful source details for the selected month.
Homocysteine Assay May Cause Elevated Results in the Folate Assay
One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery…
Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedures.
Product recalled due to potentially elevated levels of Histamines. Product supplier, TPX, is recalling product which is related to a recent scombrotoxin poisoning outbreak in US.
The outer retail packaging claims "Gluten Free" but the inner individual pouch declares wheat.
Product recalled due to potentially elevated levels of Histamines. Product supplier, TPX, is recalling product which is related to a recent scombrotoxin poisoning outbreak in US.
The outer retail packaging claims "Gluten Free" but the inner individual pouch declares wheat.
Product recalled due to potentially elevated levels of Histamines. Product supplier, TPX, is recalling product which is related to a recent scombrotoxin poisoning outbreak in US.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water…
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Chrysler (FCA US LLC) is recalling certain 2020 Jeep Wrangler vehicles. The left side lower control arm bracket and weld may not be correctly positioned.
Chrysler (FCA US LLC) is recalling certain 2019-2020 Ram 2500 and 3500 Pickup vehicles equipped with six-speed automatic (68RFE) transmissions. A build up of pressure and heat inside the…
Chrysler (FCA US LLC) is recalling certain 2014-2019 Ram ProMaster vehicles equipped 3.6L engines. The transmission shifter cable may separate and disconnect from the transmission, causing…
The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an…
The integrity of the sterile grid packaging is potentially compromised.
May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
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.