Phadia Ab - EliA RF IgM Immunoassay - Class 2 Recall
EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 2, 2019 Category: Medical Devices Source Type: alerts
Tecan US, Inc. - Freedom EVO2 - Class 2 Recall
Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 21, 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
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
Abbott Laboratories - Multichem S Plus Level 1 - Class 3 Recall
Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 17, 2019 Category: Medical Devices Source Type: alerts
Abbott Laboratories - Multichem S Plus Level 2 - Class 3 Recall
Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 17, 2019 Category: Medical Devices Source Type: alerts
NUMB520 (Lidocaine Hydrochloride, Phenylephrine Hydrochloride) Spray [Clinical Resolution Laboratory, Inc.]
Updated Date: May 16, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 16, 2019 Category: Drugs & Pharmacology Source Type: alerts
LIGHTNING PAIN RELIEF (Menthol) Cream [Clinical Resolution Laboratory, Inc.]
Updated Date: May 16, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 16, 2019 Category: Drugs & Pharmacology Source Type: alerts
DR. LIGHTENING ULTRA-POTENT FACIAL (Hydroquinone) Cream [Clinical Resolution Laboratory, Inc.]
Updated Date: May 3, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 3, 2019 Category: Drugs & Pharmacology Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - syngo Lab Data Manager System - Class 2 Recall
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data Center. It supports the Siemens analyzers through delivery of applications and connectivity features. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 19, 2019 Category: Medical Devices Source Type: alerts
DR. LIGHTENING ULTRA-POTENT FACIAL CLEANSER (Hydroquinone) Cream [Clinical Resolution Laboratory, Inc.]
Updated Date: Apr 3, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 3, 2019 Category: Drugs & Pharmacology Source Type: alerts
Abbott Laboratories - CELLDYN Emerald - Class 2 Recall
CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 30, 2019 Category: Medical Devices Source Type: alerts
Becton Dickinson & Co. - BD Synapsys Microbiology Informatics Solution - Class 2 Recall
BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient data received from external software systems allowing for the aggregation, evaluation, dissemination of knowledge using all data, anywhere, anytime. Currently Release 2 of BD Synapsys can connect to both Lab Automation (Kiestra) and BACTEC instruments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 24, 2019 Category: Medical Devices Source Type: alerts
ZN7 DERM (Zinc Gluconate) Spray [Addison Biological Laboratory, Inc.]
Updated Date: Mar 20, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 20, 2019 Category: Drugs & Pharmacology Source Type: alerts
OCUFRESH (Water) Liquid [Optics Laboratory, Inc]
Updated Date: Feb 25, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 25, 2019 Category: Drugs & Pharmacology Source Type: alerts
