FDA: Beware of Faulty Platelet Counts From B-C Analyzers - Beckman Coulter DxH 600/800/900 instruments recalled

[cujoe]

Apologies if this has already been posted. No idea if this is just US issue, but seems that all BC 600/800/900 instruments would be affected.

medpagetoday.com/hospitalba...

fda.gov/medical-devices/med...

fda.gov/news-events/press-a...

Be Well - cujoe

[81ue]

I hope all labs fix it soon, for the first time my platelets are in normal range, I'd really be sad to find out it was an elevated result due to faulty equipment

[DriedSeaweed]

Sounds dangerous

[AussieNeil Partner Administrator]

As if platelets weren't already hard enough to measure. It's common to get posts about concerning one off drops in platelet counts, which is not surprising, given platelet count instrument reading reproducibility is quite poor in comparison with other blood counts. Counts from one blood sample can vary by +/- 10 when remeasured.

Neil

[curlscurls]

Important to know about. Thanks for posting it.

[SeymourB]

Good catch, cujoe!

I wonder what model(s) the big labs in the U.S., like Quest, LabCorp, and ARUP use. I think these are smaller units aimed at hospitals.

The GoogleBird told me that the 800 is over 10 years old. The 600 is about 6 years old. The 900 came out last year.

I think these notices from FDA are not normally so widely publicized. Again, the Googlebird showed a few others:

accessdata.fda.gov/scripts/...

accessdata.fda.gov/scripts/...

accessdata.fda.gov/scripts/...

That said, there are so many models out there, and some technical faults come down to specific serial numbers.

captodayonline.com/productg...

I've been asking my specialists what models they use just for reference and for oddities like this. Some doctors simply do not know or care - not-my-department, or we-adhere-to-all-standards-tut-tut.

In the U.S., some tests are always sent out to bigger labs, some are done in-house. The big labs are mysterious, and distant in more than geographic terms.

In any case, I think we should ask for manual CBCs before treatment decisions are made.

I think that good doctors do this automatically. It might be good to get a manual CBC each year just for reference, because the automated CBCs sometimes differ from manual stats due to cell size, shape, or analyzer model.

=seymour=

[DriedSeaweed in reply to SeymourB]

I guess one plus of neutropenia is that all my blood counts get manually done! They get flagged, read out and I sometimes get a phone call. I always have to tell them not to worry my oncologist is aware!