Radiometer recall

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How many of you have Radiometer ABL90 analyzers in your departments as point of care instruments, particularly the NICU? I received the recall today stating that ctBil and FHbF are no longer FDA cleared for any sample type, and that the oximetry and pO2 are no longer valid for capillary sample types. The NICU at our facility uses the ABL90 for monitoring of their neonates nearly as often as our ED uses theirs. This change requires immediate action and therefore I will have to remove the ABL90 from the NICU completely as the only sample types they generally collect are capillary samples. What analyzers do you find are best suited for POC use in a NICU setting?

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We are in the same panicking boat!  Here for solidarity.  :)  

Hi Niki, did you receive Recall letter? If yes, do you mind posting it here? or e-mail: jagruti.patel@wellstar.org
Thanks!

We use the GEM5000 in our NICU. You'll likely find it comparable to the ABL90 with ease of use and maintenance. 

Please post the letter!

Thank you, Niki.

We received the recall as well and had a call with Radiometer. Does anyone know if this is only with Radiometer or across the board? Being an FDA clearance issue for validation testing. 

We have a call tomorrow morning with the Manuf. to discuss.  We are still reeling from the i-STAT FDA changes of approval for capillary and adding this Radiometer FDA change on top of that makes me wonder if the FDA is making a sweep of all blood gas manufacturers.  If we move to another vendor/instrument, how do i know that FDA won't make changes to that vendor as well?  

We bought the GEM 7000 for our NICU off site location. Our rep assures us that we don't have to worry about the FDA recall. But maybe that was just salesman talk. I'm hoping the addition of the hemolysis index to testing will keep the FDA recall of capillary at bay for this generation of GEM. 

We had to hurry up and switch platforms after that recall notice. We are now running our capillary specimens on the Epoc. I hope that isn't the next platform to get recalled for capillary testing.

That is exactly my thought - who is the next vendor to be evaluated and recalled.  Too much coincidence that we just had to deal with this with iSTAT, and now it's Radiometer under scrutiny.

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Niki Bradshaw
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