Instrumentation Laboratory ACL ELITE Refurbished-Analyzer designed specifically for clinical recall — FDA Z-1306-2023
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Complete FDA and NHTSA recall records dated in April 2023.
These records include useful source details for the selected month.
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.
The incorrect IFU was distributed with the devices.
Rakkyo was removed because the firm provided the updated ingredients statement to consignees. Product does not contain any allergens.
Water bottle has a cup with a screw cap attached by a weld that has been found to leach lead.
Seasoned Garlic with Salt and Vinegar was removed because the firm provided the updated ingredients statement to consignees. Product does not contain any allergens.
Cucumber Pickle was removed because the firm provided the updated ingredients statement to consignees. Product does not contain any allergens.
Seasoned Perilla Leaves was recalled due to undeclared Sesame Seeds, Soybean, Wheat, Fish (Anchovy), and Shrimp.
Perilla Leaves in Soybean Paste was recalled due to undeclared Soybean, Wheat, Fish (Anchovy, Big Eye Herring), and Shrimp.
Peanuts are declared in the ingredients statement, but they are not declared in the allergen contains statement.
Xin Ao International Group Corp, 601 E. Linden Ave Linden NJ 07036is initiating a recall of Enoki Mushroom, 200g, Plastic Bag, 25 bags per case because the product may be contaminated with…
The firm's vanilla product contains coumarin, a prohibited substance.
Seasoned Radish Sliced was recalled due to undeclared Fish (Anchovy, Big Eye Herring), Crustacean (Shrimp), Sesame.
Seasoned Fish Meat was recalled due to undeclared Fish (Pollock, Golden Threadfin Bream, Hairtail, Lizard Fish), Wheat, and Soy bean.
Stir-Fried Fish Cake was recalled due to undeclared Soybean, Wheat, Fish (Golden Threadfin Bream, Hairtail), and Sesame.
undeclared soy proteins
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
Tesla, Inc. (Tesla) is recalling certain 2023 Model X vehicles equipped with a full self-driving computer 4.0 and running software release version 2023.2.200. Weak camera signal strength…
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.