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OPTI Medical Systems Recalls
3 recalls on record · October 3, 2012 to August 25, 2021 · Medical Devices
Recalls by year
12
13
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 25, 2021Medical DevicesFDA
OPTI Medical Systems, Inc recalls OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Hazard: 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.
October 30, 2013Medical DevicesFDA
OPTI Medical Systems, Inc recalls Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in
Hazard: 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.
October 3, 2012Medical DevicesFDA
OPTI Medical Systems, Inc recalls BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to
Hazard: The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).