Is this your brand? Sign in to claim ownership.

OPTI MEDICAL SYSTEMS INC.

United States·US-MF-000027152

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
OPTI CCA -TS2 Blood Gas Analyzer	GD7046	EUDAMED	Class A	Active
Comfort Sampler, Basic Kit	1	FDA UDI	Class I	Active
OPTI Analyzer CCA TS	1	EUDAMEDFDA UDI	Class II	Active
E-Ca Cassette Carton	1	FDA UDI	Class II	Active
Comfort Sampler Bulk	1	FDA UDI	Class I	Active
OPTI CCA TS Accessory Kit	1	FDA UDI	Class II	Active
OPTI Accessory Kit	1	FDA UDI	Class I	Active
OPTI Check Plus	1	FDA UDI	Class I	Active
B Cassette	1	FDA UDI	Class II	Active
OPTI CCA E Cassette	1	FDA UDI	Class II	Active
OPTI CCA E-Glu Cassette	1	FDA UDI	Class II	Active
Comfort Sampler	1	FDA UDI	Class I	Active
OPTI Check Control Tri Level	1	FDA UDI	Class I	Active
OPTI CCA E-Cl Cassette	1	FDA UDI	Class II	Active
Opti Cca-Ts2	K131126	FDA 510(k)	Class II	Active
Opti Cca-Ts, B-Lac Cassette Model Bp7561	K093280	FDA 510(k)	Class II	Active
OPTI® B-Lac Cassette	K200986	FDA 510(k)	Class II	Active

No authorised representatives on record.

Not available yet.

Not available yet.

Not available yet.

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 25, 2021	Z-2310-2021	—	open, classified	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.
Aug 9, 2013	Z-0029-2014	—	terminated	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.
Jul 3, 2012	Z-2440-2012	—	terminated	The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).
Mar 15, 2011	Z-2558-2011	—	terminated	The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma.
Apr 20, 2009	Z-1083-2010	—	terminated	Outer box labeling shows an incorrect storage temperature range.
May 8, 2008	Z-2152-2008	—	terminated	This lot of Heparinized Capillary Tubes contain contaminated lithium heparin.
Jul 18, 2007	Z-0119-2008	—	terminated	Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at the high end of labeled storage, therefore subsequent measurements give results outside the allowed error allowance before the 6 month expiration date shown on the device.