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RECENT ACTIVITY
Danyel Olson posted a reply on Re: CHEM8 and CG4 Blue cartridge
Wednesday, Jan 15, 2020 at 2:29 PM
Said: : "I'm not sure how to interpret this letter
"Currently the chem8 and CG4 cartridges are not FDA cleared and do not have CLIA waived status".
We only use as non-waived , but I think the "not FDA cleared" statement still applies?
Anybody kn...
Kelley Benson posted a reply on Re: CHEM8 and CG4 Blue cartridge
Wednesday, Jan 15, 2020 at 2:25 PM
Said: : "https://www.pointofcare.abbott/shared/static-assets/other/APOC2020-001 CHEM8 CG4 capillary and CLIA notification letter FINAL.pdf
https://www.pointofcare.abbott/shared/static-assets/other/2020 01 08 APOC 2020-002 Discontinuation G3+ 6...
Bonnie Brannan posted a new Topic
Wednesday, Jan 15, 2020 at 2:17 PM
Different Letters from Abbott
: "Evidently Abbott has issued different letters to Customers. The letter I received today Says that Abbott will not longer market the G3 (Blue), 6+ (White), EC4+ (white), E3+ (White) Effect May 1st, 2020.
Goes on to say the performance of the I-Sat G3+ has not been fully characterized by Abbott.
What do they mean by characterized?
Mercy me.
..."
Ronda Owen posted a reply on Re: CHEM8 and CG4 Blue cartridge
Wednesday, Jan 15, 2020 at 2:01 PM
Said: : "If the cartridges are awaiting FDA approval wouldn't that make them LDTs and highly complex?"
Liz Owusu posted a reply on Re: CHEM8 and CG4 Blue cartridge
Wednesday, Jan 15, 2020 at 1:57 PM
Said: : "https://www.pointofcare.abbott/shared/static-assets/other/APOC2020-001%20CHEM8+%20CG4+%20capillary%20and%20CLIA%20notification%20letter%20FINAL.pdf
it is also on the Abbott website"
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