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Sources: EU EUDAMED, US FDA
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VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293
FDA Enforcement
Class II
·Terminated·Ortho Clinical Diagnostics Inc·January 20, 2021
VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively measure (ALB) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·November 27, 2013
Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Custom procedural trays or kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
FDA Enforcement
Class I
·Terminated·Merit Medical Systems, Inc.·February 26, 2014
Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.
FDA Enforcement
Class II
·Terminated·Focus Diagnostics Inc·March 12, 2014
The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur, and test results are generated for each analyte independently of the other analyte. The ALB test is a multilayered, analytical element coated on a polyester support. For the albumin measurement, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. When the fluid penetrates the reagent layer, the bromocresol green (BCG) dye diffuses to the spreading layer and binds to albumin in the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the concentration of albumin in the sample. Model/Catalog Number: 6844293
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·August 28, 2024
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
FDA Enforcement
Class I
·Ongoing·Medline Industries, LP·October 8, 2025
VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292
FDA Enforcement
Class II
·Terminated·Ortho Clinical Diagnostics Inc·January 20, 2021
Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CREA_2, CRE_2c, ECRE_2), Glucose Hexakinase (GLUH), Glucose Oxidase (GLUO), Iron (IRON_2), Lithium (LITH), Magnesium (MG, MG_c), Phosphorus - inorganic (IP, IP_c), Total Protein (TP, TP_c), Triglycerides (TRIG), Urea Nitrogen (UN, UN_c), Uric Acid (UA, UA_c)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·November 23, 2016
Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based products formulated for use as a reference material when calibrating Beckman Coulter AU clinical chemistry system assays. The calibrators are used to calibrate the following assays: Albumin (ALB), Bicarbonate (CO2), Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Calcium Arsenazo (CALA), Calcium (CAL oCPC), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Phosphorus (PHOS), Iron, Lactate, Magnesium (MG), Total Protein (TP), Triglyceride (TRIG), Unbound Iron Binding Capacity (UIBC), Urea Nitrogen (BUN), and Uric Acid. Only lots 6101K51 and 6101K61 were subject to recall.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·February 21, 2018
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Procedure Tray (Paracentesis Tray kit), REF: SPPT-100/D SPPT-5F-10/D SPPT-5F-10L/B SPPT-5F-10S SPPT-5F-12PL SPPT-5F-17PL SPPT-5F-7/D SPPT-5F-7L/B SPPT-5F-7S SPPT-6F-10L SPPT-6F-10S SPPT-6F-10S SPPT-6F-12PL SPPT-6F-17PL SPPT-8F-10L SPPT-8F-12PL TAPS-100 TAPS-5F-10LT TAPS-5F-10T TAPS-5F-12PLT TAPS-5F-17PLT TAPS-5F-7LT TAPS-5F-7T TAPS-6F-10LT The Safety Paracentesis Procedure Tray is intended for drainage of fluid and specimen collection for diagnostic purposes or to remove excess fluid collections.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024
AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider.
FDA Enforcement
Class II
·Terminated·Ansh Labs, LLC·January 20, 2021
Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, Alpharetta, GA 30076, UPC Code 80702-1 Product Usage: The product is a nonprescription, topical gel that is used to enhance libido and stimulate orgasmic pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0 Product Usage: A topical gel that increases sexual excitement and pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical gel that increases men and womens secual excitement and pleasure.
FDA Enforcement
Class II
·Ongoing·Altasource LLC dba Meta Labs LLC·April 30, 2014
Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD, Franklin Lakes, NJ. The kit is used by health care providers when treating patients.
FDA Enforcement
Class II
·Terminated·Heritage Labs International LLC·April 24, 2013
Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline. The HeartMate 3 System Controller constantly monitors system performance through communication with the implanted LVAD and Controller internal measurements and alerts the user to any alarm conditions by activating membrane panel LEDs and integrated audio annunciators. Further information on alarm conditions as well as system status can be attained by the user from the front panel LCD on the System Controller. When connected to a HeartMate Touch" Communication System, the System Controller sends information regarding the System Controller and Pump Status once per second to provide additional information to the user. This link also allows the clinician to set new patient operating parameters (e.g. pump speed) and provides a link for downloading trend and/or event recorder data. Component: Yes, HeartMate 3 Left Ventricular System (LVAS) Kits
FDA Enforcement
Class II
·Ongoing·Thoratec LLC·June 24, 2026
Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3" System Controller and provides power to the System Controller. The HeartMate System Controller is an external device that manages the HeartMate Left Ventricular Assist System (LVAS), including alarms, system monitoring, and communication. It contains an internal 11V lithium-ion backup battery that provides at least 15 minutes of emergency power should the main system power source fail. The backup battery must be properly installed, charges automatically during normal use, and has a 36-month service life from date of manufacture. Component: Yes, HeartMate 3" System Controller
FDA Enforcement
Class II
·Ongoing·Thoratec LLC·June 24, 2026
Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
FDA Enforcement
Class II
·Ongoing·Covidien LLC·June 10, 2026
Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044
FDA Enforcement
Class II
·Ongoing·Covidien LLC·June 10, 2026