Inpeco S.A. - Inpeco SA - Class 2 Recall
Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts
Radiometer Medical ApS - ABL 90 FLEX PLUS - Class 2 Recall
ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2020 Category: Medical Devices Source Type: alerts
Radiometer Medical ApS - ABL90 FLEX - Class 2 Recall
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2020 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - LabPro Data Management System - Class 2 Recall
LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 7, 2020 Category: Medical Devices Source Type: alerts
Greiner Bio-One North America, Inc. - VACUETTE TUBE - Class 2 Recall
VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 18, 2020 Category: Medical Devices Source Type: alerts
The Binding Site Group, Ltd. - Optilite CReactive Protein Kit - Class 2 Recall
Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite anal...
Source: Medical Device Recalls - December 13, 2019 Category: Medical Devices Source Type: alerts
Randox Laboratories Ltd. - Rheumatoid Factor Calibrators - Class 2 Recall
Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syphilis. However, in these conditions the RF titre is much lower than in rheumatoid arthritis. This test kit must be used by suitably q...
Source: Medical Device Recalls - November 5, 2019 Category: Medical Devices Source Type: alerts
CooperSurgical, Inc. - RI Witness Embryology Heated Plate - Class 3 Recall
Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated t...
Source: Medical Device Recalls - October 3, 2019 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc - Atellica IM antiCCP IgG (aCCP) Assay - Class 2 Recall
Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma (K2-EDTA, lithium heparin) using the ADVIA Centaur XP system. Detection of anti-CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-crite...
Source: Medical Device Recalls - September 27, 2019 Category: Medical Devices Source Type: alerts
House Of Spices (India) Issues Recall of " MDH Sambar Masala " Due To Salmonella Contamination
House of Spices (India) is recalling different lots of “MDH SAMBAR MASALA”, 3.5oz (100g) UPC code 6291103750327. This product is produced by R-PURE AGRO SPECIALITIES and distributed by HOUSE OF SPICES (INDIA). This product was tested by FDA through a certified laboratory to be positive for Salmonell (Source: FDA Food Safety)
Source: FDA Food Safety - September 9, 2019 Category: Food Science Authors: FDA Source Type: alerts
House Of Spices (india) Issues Recall of "MDH Sambar Masala" Due To Salmonella Contamination
House of Spices (India) is recalling different lots of “MDH SAMBAR MASALA”, 3.5oz (100g) UPC code 6291103750327. This product is produced by R-PURE AGRO SPECIALITIES and distributed by HOUSE OF SPICES (INDIA). This product was tested by FDA through a certified laboratory to be positive for Salmonell (Source: FDA Food Safety)
Source: FDA Food Safety - September 7, 2019 Category: Food Science Authors: FDA Source Type: alerts
Instrumentation Laboratory Co. - ROTEM extem (for use on ROTEM delta instrument) - Class 2 Recall
ROTEM ex-tem Canada Part No: 503-05-CA (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 7, 2019 Category: Medical Devices Source Type: alerts
Instrumentation Laboratory Co. - ROTEM extem (for use on ROTEM delta instrument) - Class 2 Recall
ROTEM ex-tem Rest of the world part No: 503-05 (ROW) (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 7, 2019 Category: Medical Devices Source Type: alerts
Instrumentation Laboratory Co. - ROTEM extem (for use on ROTEM delta instrument) - Class 2 Recall
ROTEM ex-tem; US Part No: 503-05-US (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 7, 2019 Category: Medical Devices Source Type: alerts
Hycor Biomedical Inc - Autostat II Rheumatoid Factor IgM ELISA - Class 2 Recall
AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR Hy...
Source: Medical Device Recalls - July 31, 2019 Category: Medical Devices Source Type: alerts
