9 results
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Sources: EU EUDAMED, US FDA
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FDA Recall
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OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma.
FDA Recall
Terminated
·OPTI Medical Systems, Inc·Product code CGZ·April 20, 2009
Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.
FDA Recall
Terminated
·OPTI Medical Systems, Inc·Product code JJE·August 9, 2013
OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). Cassettes are consumables used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma. . Cassettes contain one-time use sensors that are used with the OPTI-LION analyzer to perform in-vitro measurements of electrolytes. OPTI LION E-Plus Cassettes are supplied in boxes of 25 and may only be used with the OPTI LION Electrolyte Analyzer.
FDA Recall
Terminated
·OPTI Medical Systems, Inc·Product code CGZ·March 15, 2011
OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076
FDA Recall
Terminated
·Opti Medical Systems Inc·Product code JGS·July 18, 2007
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
FDA Recall
Open, Classified
·OPTI Medical Systems, Inc·Product code QJR·June 25, 2021
BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point of care locations. Cassettes contain one-time use sensors that are used with the OPTI CCA-TS analyzer to perform in-vitro measurements of blood gases and metabolites. OPTI CCA-TS B-Lac Cassettes are supplied in boxes of 25 and may only used with the OPTI CCA-TS Analyzer.
FDA Recall
Terminated
·OPTI Medical Systems, Inc·Product code CHL·July 3, 2012
Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app. 200l, Heparinized: 6 IU Na & 9 IU Li/100 l,
FDA Recall
Terminated
·Opti Medical Systems Inc·Product code GIO·May 8, 2008
AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS System, X-Ray, Fluoroscopic, image-intensified; solid state x-ray imager (flat panel/digital imager)
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MQB·January 14, 2011
ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
FDA Recall
Terminated
·Alphatec Spine, Inc.·Product code KWP·July 6, 2011