An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 ยฟg/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 ยฟg/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives.
All Recalls
92,900 total recalls in our database
STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz
Sorin Group USA
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Medtronic Perfusion Systems
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery
Medtronic Perfusion Systems
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
STOCKERT Heater-Cooler System 3T, 127V/60 Hz
Sorin Group USA
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
PerkinElmer Health Sciences
PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
Mini barrel charcoal grills
Bazhou Sanxin Steel, of China
The exterior paint on the grill can ignite, posing a fire hazard.
Children's two-piece woven pajama sets
Unknown Manufacturer
The children's pajamas fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
Liquid glitter iPhone cases
Unknown Manufacturer
Liquid and glitter can leak out of the cases, causing skin irritation and burns to consumers.
Children's magnetic building sets
Unknown Manufacturer
The building sets corner welds can break, allowing the panels and frames to separate and release magnets during play. When released, exposed magnets can create a choking hazard.
AccuPure floor-standing filtration dispensers
Water Solutions (Hong Kong) Limited of Hong Kong
The dispensers can overheat and smoke, posing fire and burn hazards.
Write Againยฎ magnetic dry erase white boards
Unknown Manufacturer
The thin magnetic metal surface can separate from the product's wooden board, posing a laceration hazard.
A96555, PREDUST X2, NET WT 50 LBS, Manufactured By: Newly Weds Foods, Inc., Chicago, IL 60639
Newly Weds Foods
Product may contain undeclared milk.
B4016W, 910277 Breader, NET WT 40 LBS, Manufactured By: Newly Weds Foods, Inc., Chicago, IL 60639
Newly Weds Foods
Product may contain undeclared milk.
B93756, BREADER X1@, NET WT 40 LBS, Manufactured By: Newly Weds Foods, Inc., Chicago, IL 60639
Newly Weds Foods
Product may contain undeclared milk.
B4AAF3, BREADER X1, NET WT 50 LBS, Manufactured By: Newly Weds Foods, Inc., Chicago, IL 60639
Newly Weds Foods
Product may contain undeclared milk.
B2ADU3, BATTER MX X1*, NET WT 50 LBS, Manufactured By: Newly Weds Foods, Inc., Chicago, IL 60639
Newly Weds Foods
Product may contain undeclared milk.
B52432, BREADER X3@, NET WT 50 LBS, Manufactured By: Newly Weds Foods, Inc., Chicago, IL 60639
Newly Weds Foods
Product may contain undeclared milk.
Firm was notified by supplier that cashew butter used in protein bars is under recall due to the potential of Listeria monocytogenes.
A40126, BREADER X1, NET WT 50 LBS, Manufactured By: Newly Weds Foods, Inc., Chicago, IL 60639
Newly Weds Foods
Product may contain undeclared milk.