OCUFRESH (water) liquid [Optics Laboratory Inc.]
Updated Date: Tue, 31 Oct 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - October 31, 2023 Category: Drugs & Pharmacology Source Type: alerts
MINIDROPS (lubricant eye drops) liquid [Optics Laboratory, Inc]
Updated Date: Tue, 31 Oct 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - October 31, 2023 Category: Drugs & Pharmacology Source Type: alerts
Instrumentation Laboratory - Werfen - Class 2 Recall
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097 (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2023 Category: Medical Devices Source Type: alerts
GAMMAPLEX (human immunoglobulin g) solution [Bio Products Laboratory Limited]
Updated Date: Thu, 10 Aug 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 10, 2023 Category: Drugs & Pharmacology Source Type: alerts
DR ACNE WASH FACIAL CLEANSER (benzoyl peroxide) cream [Clinical Resolution Laboratory, Inc.]
Updated Date: Fri, 04 Aug 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 4, 2023 Category: Drugs & Pharmacology Source Type: alerts
Cytocell Ltd. - RET Distal Probe - Class 2 Recall
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 21, 2023 Category: Medical Devices Source Type: alerts
Cytocell Ltd. - RET Proximal Probe - Class 2 Recall
RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 21, 2023 Category: Medical Devices Source Type: alerts
GAMMAPLEX (human immunoglobulin g) solution [Bio Products Laboratory Limited]
Updated Date: Fri, 07 Jul 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - July 7, 2023 Category: Drugs & Pharmacology Source Type: alerts
BioReference Health, LLC - The 4Kscore Test - Class 2 Recall
The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patient s age, previous biopsy, and digital rectal exam (DRE). Patient s file (sample type, prior biopsy status, DRE status and age) are uploaded to the Specimen Processing Module (SPM). The results from the four assays are exported automatically to Lab Manager Application (B2 LIS) which automatically triggers the 4Kscore calculatio...
Source: Medical Device Recalls - June 3, 2023 Category: Medical Devices Source Type: alerts
COLLOIDAL IODINE SOLUTION (sodium iodide) solution [JCI Colloidal Iodine Laboratory Co., Ltd.]
Updated Date: Wed, 24 May 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 24, 2023 Category: Drugs & Pharmacology Source Type: alerts
COLLOIDAL IODINEINJECTION (iodine) solution [JCI Colloidal Iodine Laboratory Co., Ltd.]
Updated Date: Fri, 19 May 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 19, 2023 Category: Drugs & Pharmacology Source Type: alerts
CORRECTION NOTICE: New Hampshire Laboratory Error Incorrectly Resulted in Recall of l ēf Farms “Spice” Packaged Salad Greens: Recall Canceled
– The New Hampshire Department of Health and Human Services (DHHS) has determined that a laboratory error incorrectly caused last week’s recall announcement concerning lēf Farms “Spice” Packaged Salad Greens. The products from lēf Farms are safe and the recall has been canceled. On May 5, a press (Source: FDA Food Safety)
Source: FDA Food Safety - May 11, 2023 Category: Food Science Authors: FDA Source Type: alerts
Inpeco S.A. - FlexLab (FLX), Accelerator a3600 (ACP), and Aptio Automation (AP2) - Class 2 Recall
Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 5, 2023 Category: Medical Devices Source Type: alerts
Inpeco S.A. - FlexLab (FLX), Accelerator a3600 (ACP), and Aptio Automation (AP2) - Class 2 Recall
Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 5, 2023 Category: Medical Devices Source Type: alerts
Inpeco S.A. - FlexLab (FLX), Accelerator a3600 (ACP), and Aptio Automation (AP2) - Class 2 Recall
Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 5, 2023 Category: Medical Devices Source Type: alerts
