Microbiologics Inc - HELIXELITE SARSCoV2 Process Control (Pellet) - Class 2 Recall
SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2021 Category: Medical Devices Source Type: alerts
Microbiologics Inc - HELIXELITE SARSCoV2 Process Control (Swab) - Class 2 Recall
SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2021 Category: Medical Devices Source Type: alerts
BioMerieux SA - VITEK 2 instrument using MYLA V4.8.0/4.8.1 and MYLA V4.7.1 software - Class 2 Recall
MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 7, 2021 Category: Medical Devices Source Type: alerts
Microbiologics Inc - KWIKSTIK - Class 2 Recall
Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for the detection and identification of a cultured microorganism isolate. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 6, 2020 Category: Medical Devices Source Type: alerts
Microbiologics Inc - KWIKSTIK - Class 2 Recall
Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 28, 2020 Category: Medical Devices Source Type: alerts
Microbiologics Inc - KWIKSTIK - Class 2 Recall
Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845357030770, (17)200831, (10)5195-04. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 10, 2020 Category: Medical Devices Source Type: alerts
Microbiologics Inc - KWIKSTIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog 0778P, lot 778653) - Class 2 Recall
KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3) (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 10, 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
Microbiologics Inc - Microbiologics QC Sets and Panels - Class 2 Recall
Vaginal Verification Panel Ref 8208 Lot 8208-11 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2020 Category: Medical Devices Source Type: alerts
Microbiologics Inc - GramPositive Blood Culture Control Panel (Inactivated Pellet) - Class 2 Recall
Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 17, 2020 Category: Medical Devices Source Type: alerts
Microbiologics Inc - Cepheid Xpert C. difficile/Epi Control Panel - Class 3 Recall
Cepheid Xpert C. difficile/Epi Control Panel (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 19, 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
Microbiologics Inc - Assayed quality control material for microbiology assays - Class 2 Recall
Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 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
