The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU) reagent on-board stability claims, which may cause control failures and/or erroneous patient samples results. The Complaint handling unit has received a total of 2 safety cases (CASE-2023-02027212 and CASE-2023-02045278) and 99 quality cases with the failure mode attributed to Transferrin reagent (OSR6152 / lot 2573) associated with reagent blank shifts for the Reagent 2 (R2), imprecision, calibration failures, erratic Quality Control (QC) recoveries, and/or erroneous high/low (serum, plasma, urine) patient results. The issue was confirmed through internal testing by Beckman Coulter on June 30, 2023. Reagent Blank shifts for R2, imprecision, calibration failures, erratic Quality Control (QC) recoveries, and/or erroneous high/low (serum, plasma, urine) patient results. The issue was confirmed through internal testing by Beckman Coulter on June 30, 2023.
All Recalls
95,114 total recalls in our database
LYFO-DISK, P. venetum, Catalog number 0794L
Microbiologics
A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562
MEDLINE INDUSTRIES, LP - Northfield
This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.
Philips North America
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
Balloon Time Mini Helium Tanks
Unknown Manufacturer
Compressed helium from the tank can escape and cause the plastic cap to be released into the air unexpectedly, posing an injury hazard due to projectiles striking users and bystanders.
Lenovo USB-C Laptop Power Banks
Unknown Manufacturer
The power bank's internal screws can come loose, causing a short circuit and overheating of the lithium-ion battery, posing a fire hazard. Do not put lithium-ion batteries in the trash or battery recycling boxes found at various retail and home improvement stores. They can cause fires and explosions if they are damaged or crushed and are a hazard when thrown in the trash.
MI 1615 and 1617 Sliding Glass Doors; Window World 4000 Series and 8000 Series Sliding Glass Doors
MI Windows and Doors LLC, of Harrisburg, Pennsylvania
The glass can separate from the frame during hurricane conditions which can pose a serious injury hazard.
PandaEar Stainless Steel Toddler Cups, 8 oz.
Unknown Manufacturer
The bottom exterior of the recalled stainless-steel cups contains an accessible solder bead with levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health effects. In addition, the lid can crack and break during use producing sharp edges and small parts, posing choking and laceration hazards to children.
ZLINE 30-inch, 36-inch and 48-inch RG gas ranges
Unknown Manufacturer
The oven of the gas ranges can emit dangerous levels of carbon monoxide (CO) while in use, posing a serious risk of injury or death from carbon monoxide poisoning.
Women's high heeled sandals (Spring Summer 2024 collection, Louisa, Linden and Seigel Heel Sandals)
Unknown Manufacturer
The heels on the shoes can detach, posing a fall hazard.
LAOION Children's Cups
Unknown Manufacturer
The bottom exterior of the stainless-steel cups contains an accessible solder bead with levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health effects. In addition, the lid can crack and break during use producing sharp edges and small parts, posing choking and laceration hazards to children.
13-Piece Toy Mushroom Peg Sorters
Unknown Manufacturer
The stems of the toy mushrooms can detach, posing a choking hazard to young children.
Red Shed® Hammock Swing Chairs
Unknown Manufacturer
A plastic buckle that supports the back of the chair can break when a consumer is seated in the chair, posing a fall hazard.
Potential contamination with Salmonella Thompson
The Sausage Maker Instacure #1
The Sausage Maker
Contains Sodium Nitrite recalled for potential metal contamination
Products are a choking hazard
Potential contamination with Salmonella Thompson
Little Bear Fresh Kale, Net Wt. 16oz
Safeway Fresh Foods
Possible Listeria monocytogenes contamination
Potential contamination with Salmonella Thompson