12 results
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84ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Precision Disposable Products
FDA UDI
PRECISION DISPOSABLE PRODUCTS INC·00865773000370·ECG Electrodes Case - Teardrop
Precision Disposable Products
FDA UDI
PRECISION DISPOSABLE PRODUCTS INC·00865773000363·ECG Electrodes Case - Teardrop
Precision Disposable Products
FDA UDI
PRECISION DISPOSABLE PRODUCTS INC·00865773000332·ECG Electrodes Case - Square
Precision Disposable Products
FDA UDI
PRECISION DISPOSABLE PRODUCTS INC·00865773000301·ECG Electrodes Case - Circle
Precision Disposable Products
FDA UDI
PRECISION DISPOSABLE PRODUCTS INC·00865773000349·ECG Electrodes Case - Square
Precision Disposable Products
FDA UDI
PRECISION DISPOSABLE PRODUCTS INC·00865773000318·ECG Electrodes Bag - Circle
LEEP PRECISION
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HGI·June 17, 2022
ALERE DETERMINE HIV-1/2 AG/AB COMBO
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·January 28, 2020
INFUSOMAT SPACE
FDA Adverse Event
Malfunction
·B.BRAUN MELSUNGEN AG·Product code FRN·October 5, 2022
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
FDA Recall
Terminated
·Epocal·Product code CGA·March 13, 2013
Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.
FDA Recall
Terminated
·Lin-Zhi International Inc·Product code JJW·February 6, 2014
Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.
FDA Recall
Terminated
·Lin-Zhi International Inc·Product code DLJ·February 6, 2014