OPTI Medical Systems

3 recalls •

• Categories: Diagnostic Equipment, Other Medical Devices

OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004

Class I - Dangerous

The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix.

Jun 25, 2021 Diagnostic Equipment View Details →

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.

Class I - Dangerous

OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures.

Aug 9, 2013 Other Medical Devices Nationwide View Details →

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.

Class I - Dangerous

The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).

Jul 3, 2012 Other Medical Devices Nationwide View Details →