The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide.
All Recalls
95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are a CT-1000-100.
SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.
JK Products & Services
🏥 Medical Devices Class I - Dangerous
The integrity of the wires inside main electrical chord become compromised from excessive flexing (during the door open/close process).
🏥 Medical Devices Class I - Dangerous
Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
🏥 Medical Devices Class I - Dangerous
Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on the product label.
🏥 Medical Devices Class I - Dangerous
Not approved labeling claims (antimicrobial and autolytic debridement)
VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
🏥 Medical Devices Class I - Dangerous
Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become Treated (completed) status on the exact day when such change is made, to Untreated status. Furthermore, such treatment would be cloned and mistakenly added to the schedule as Untreated treatment
🏥 Medical Devices Class I - Dangerous
suction canister lids may have occluded ports.
🏥 Medical Devices Class I - Dangerous
During a Field Test (a customer external evaluation period), the customer detected a problem in the CIRS 4.0 Beta 2 software. When using the CIRS 4.0 Beta 2 software, during the recon during ready stage of reconstruction, images may be overlapped with, or superimposed on other images. Philips has disabled this feature at all sites evaluating 4.0 Beta 2 software. Philips will issue a software up
Sterility of device is not assured
🏥 Medical Devices Class I - Dangerous
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
🏥 Medical Devices Class I - Dangerous
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
🏥 Medical Devices Class I - Dangerous
Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used with BCCV.
Gas fireplaces, gas stoves, gas inserts and log sets
Hearth & Home Technologies, of Lakeville, Minn.
🏠 Consumer Products Class I - Dangerous
The gas valve in the unit can leak, posing a fire hazard.
SBGA-34 Audible Fire Alarm Base
Beijing Siemens Cerberus Electronics Ltd., of China
🏠 Consumer Products Class I - Dangerous
The fire alarm base can fail to sound an alarm, posing a risk of personal injury and property damage.
Roundy's Salsa Con Queso; NET WT; 16 OZ (1 LB) 454g; DISTRIBUTED BY Roundy's Milwakee, WI 53202. Distributed in cases of 12/16 W jars.
Durrset Amigos
🍎 Food Class I - Dangerous
Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.
Marjon Kale Sprouts, Keep Refrigerated. NET WT. 6/3 oz. packaged in cups; Marjon Specialty Foods, Inc. 3508 Sydney Rd., Plant City, FL 33567 Grown and Packed in the USA. UPC 20077554000231. Used by 7/06/14.
Marjon Specialty Foods
🍎 Food Class I - Dangerous
Firm environmental samples found Listeria in the sprout production area.
🍎 Food Class I - Dangerous
Firm is initiating a voluntary recall of Fresh Farmed Atlantic Salmon and Fresh Wild Tuna because it has the potential to be contaminated with Listeria monocytogenes. Firm was notified that FDA environmental swab samples had a positive result for Listeria monocytogenes.
Grace Classic Coconut Milk Net 13.5 FL OZ (US) (400 mL) PRODUCT OF THAILAND Packed for: GraceKennedy Limited, 73 Harbour Street Kingston, Jamaica, W.I.
Grace Foods (USA)
🍎 Food Class I - Dangerous
Label misprint on the front panel. Incorrectly declaring "No Gums, Thickeners or Stabilizers Added"
Laura Lynn French Onion; DIP; NET WT 9 OZ (255g); DISTRIBUTED BY INGLES MARKETS, INC.; ASHEVILLE, NC 28816. Shipped in cases of 12.
Durrset Amigos
🍎 Food Class I - Dangerous
Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.