Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two issues affecting the FeNO readings: 1) Drift in the calibration gases and 2) Software error. Each of these issues can cause FeNO scores/results to be erroneously high.
All Recalls
95,114 total recalls in our database
bioMΒΏrieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEKΒΏ 2 do not match the results sent to the LIS and the Laboratory Technician would need to change results in the LIS to match those in the VITEKΒΏ 2. If the isolate is sent more than once to LIS, a software defect prevents the system from sending the expertised interpretation results and the Therapeutic Corrections (TC) is not sent to Laboratory Information Systems (LIS).
Femoral Angiography Drape Sterile
Cardinal Health 200
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Baxter Healthcare
Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.
In-View Clear Leggings Bulk Non-Sterile
Cardinal Health 200
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.
PureLine 1.5 HP Pool Pump Motors
Unknown Manufacturer
The pool pump motors can overheat, posing a fire hazard.
KTM, Husqvarna and GASGAS closed course competition motorcycles
KTM AG, of Austria
The drive chain can break, posing a crash hazard and/or property damage.
Model Year 2020-2021 RANGER 1000 and RANGER CREW 1000, Model Year 2020 ProXD 2000G and 4000G, Model Year 2020-2021 Ariens/Gravely JSV3200, JSV3400, and JSV6400, Model Year 2020 Bobcat UV34 4x4 GAS and UV34 XL GAS, and Model Year 2021 Bobcat UV34 4x4 GAS
Polaris Inc., of Medina, Minn.
The drive belt can break during operation and damage the inner clutch cover assembly and fuel line, which can result in a fuel leak, posing a fire hazard.
Tahina Sesame Paste packaged in 1lb and 2lb plastic jars and 10kg metal containers; UPC CODES 6215000382207
KAREEM MART
Product tested positive for Salmonella.
Alqosh Sesame Oil "Tahin" packaged in 2lb plastic jars
Mediterranean Food
Product tested positive for Salmonella.
Amazon Kitchen, Avocado Chicken Salad Sandwich, Net Wt. 8.1 oz., Cello wrap with cardboard liner, 1 unit per package, Perishable Keep Refrigerated
Flying Food Group
Flying Food Group, LLC , initiated a recall of Amazon Kitchen Avocado Chicken Salad Sandwich . The soy allergen is undeclared on the finish product label. The label does have the following statement "Prepared on shared equipment with other foods that contain eggs, fish, milk, peanut, shellfish, soy, tree nuts and wheat".
Undeclared pecans in chocolate covered pretzels
MN Milk Bank for Babies Pasteurized Donor Human Milk. Volumne 4.0 fl oz., 120 mL
Minnesota Milk Bank for Babies
Pasteurized donor human milk may contain trace amounts of dextromethorphan.
Electrolit Fruit Punch Zero, 625ML/21OZ packaged in a polypropylene bottle with volume capacity of 625mL and with a polypropylene lid and liner with a high-density polyethylene safety ring.
Laboratorios Pisa Sa De Cv
Product contains undeclared FD&C Red No. 40.
Product contains undeclared FD&C Red No. 40.
Java Frozen Tuna Steaks - 10 oz. Net Wt. 10 lb. - Approximately 15-18 pieces individually vacuum packed. Product of Indonesia - Wild Caught.
Seafood Imports Distributors
FDA Sample found Salmonella in one lot of 10 oz. frozen tuna steaks.
Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
Teva Pharmaceuticals USA
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01
Bryant Ranch Prepack, Inc.
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
Breckenridge Pharmaceutical
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.