Biomerieux Inc - PPM CLINICAL CRAPONNE - Class 2 Recall
PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 5, 2023 Category: Medical Devices Source Type: alerts
Biomerieux Inc - PPM CLINICAL MADRID - Class 2 Recall
PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524 (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 5, 2023 Category: Medical Devices Source Type: alerts
Mckesson Medical-Surgical Inc. Corporate Office - Consult, Sofia, Alere San Diego, Quickvue - Class 2 Recall
Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests, Model Number: 5003. b. QUIDEL Sofia TEST KIT, STREP A+ SOFIA (25/KT 12KT/CS) Model Number: 20274. c. Alere SAN DIEGO INC McKesson TEST, KIT STREP A DIPSTICK WAIVED (50/KT) Exempt Catalog #4999. d. In-Line Control Swab Quickvue In-Line Strep A Test Positive Level / Negative Level 12 Swabs (IVD) Catalog # 00345 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 27, 2022 Category: Medical Devices Source Type: alerts
MRSA NOSODE 4440 (mrsa nosode) liquid [Professional Complementary Health Formulas]
Updated Date: Tue, 01 Mar 2022 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 1, 2022 Category: Drugs & Pharmacology Source Type: alerts
Roche Molecular Systems, Inc. - cobas 4800 System, cobas z 480 analyzer - Class 2 Recall
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and detection for human samples within the system. The cobas x 480 instrument and cobas z 480 analyzer are to be used by laboratory professionals trained in laboratory techniques and by instruction on the use of the system and analyzer. In the U.S. the cobas z 480 analyzer is used for automated amplification and detection purposes for the following assays: co...
Source: Medical Device Recalls - January 13, 2021 Category: Medical Devices Source Type: alerts
Hardy Diagnostics - G307HardyCHROM MRSA - Class 2 Recall
HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). Not intended to diagnose infection of guide therapy. Further testing required for susceptibility or typing. Container Type: 15 x 100mm monoplate Packaged: 10 plates/sleeve STORAGE: 2-8 degree C on receipt, LIGHT SENSITIVE IVD UDI: (01)08165760201400 (10)447694 (17)191206 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 10, 2020 Category: Medical Devices Source Type: alerts
Becton Dickinson & Co. - Kit BD Max MRSA - Class 2 Recall
Kit BD Max MRSA; Catalog # 442953 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2019 Category: Medical Devices Source Type: alerts
Becton Dickinson & Co. - Class 2 Recall
Kit BD Max MRSA XT; Catalog # 443461 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2019 Category: Medical Devices Source Type: alerts
Bio-Rad Laboratories, Inc - MRSASelect - Class 2 Recall
MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 7, 2019 Category: Medical Devices Source Type: alerts
Bio-Rad Laboratories, Inc - MRSASelect II - Class 2 Recall
MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 7, 2019 Category: Medical Devices Source Type: alerts
Microbiologics Inc - Assayed quality control material for microbiology assays - Class 2 Recall
Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 5, 2019 Category: Medical Devices Source Type: alerts
American Contract Systems, Inc. - Powdered Surgical Glvoes - Class 2 Recall
Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2018 Category: Medical Devices Source Type: alerts
Roche Molecular Systems, Inc. - Cobas - Class 2 Recall
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2018 Category: Medical Devices Source Type: alerts
Cepheid - Xpert MRSA - Class 2 Recall
Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for nasal colonization (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 17, 2016 Category: Medical Equipment Source Type: alerts
Hardy Diagnostics - HardyCHROM MRSA - Class 2 Recall
HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive www.HardyDiagnostics.com Santa Maria, CA 93455 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 27, 2015 Category: Medical Equipment Source Type: alerts
