We got our recall letter from Immucor for the Fetal Screen kit on July 2nd, for a lot number that expires on July 3rd, that way Immucor doesn't have to issue replacement kits.

Immucor is currently THE ONLY supplier of a Fetal Screen kit. Ortho pulled their kit off the market as they were never able to resolve their problems with it. Their rep claims they are working on getting a kit to market again.

I also don't like the fact that Immucor ships red cell products without ice. I work in FL. Those cells are sitting on trucks where the temperature must exceed 100F before being delivered.

I am on the other side of the planet from USA and my reagent cells are also flown in without being stored in ice.

My check cells sometimes have a tendency of haemolysing and after washing and resuspending in Cell Stab, I find out that I end up with a lot lesser cells to use.

Luckily my A1 cells and B cells do not appear to have any problems yet.

Dear Brenda,

I felt sad when I read your comments. It is unfortunate that you perceive it to be tacky for another vendor to contact you to offer alternative reagent products as an option, if indeed, the FDA follows through on their statements in the NOIR letter, implements a consent decree and revokes Immucor's license to manufacture one or more of their reagent products. Perhaps this will not occur. Hopefully, for the sake of all involved, it won't.

However, there is always potential that it could - particularly since the FDA did this to Abbott back in 1999, once they knew there were sufficient other FDA-licensed, approved methods and vendors available to supply the market with the needed reagent alternatives. Vendors are people, too - just like you. They have lives and families to support -just like you. They have a job to do - just like you. Please respect them for doing it. If you don't want to have other vendor alternatives and are happy paying double the amount for your blood bank reagents year after year to Ortho and/or Immucor (or happy to ask your employer to do so), then okay - that's a choice you make and your right to make it. If your Lab Director supports you on that choice, great. Fortunately, not everyone in the blood banking world sees things as you do. Judge not lest thou be...

Mary Carpenter, B.S. MT(ASCP)

former Laboratory Director & Donor Testing Center Supervisor

Tru Mary, but there are acceptable ways of trying to sell your goods and ways that are commonly thought to be unacceptable.

I think Brenda feels that the way she was approached was of the latter way, particularly by the inclusion of the copy of the letter from the FDA. This kind of approach smacks of gloating about other firms' problems, rather than helpful advice, and I would have been a little taken aback too if that had been sent to me.

All that being said, I'm quite sure that Brenda is capable of answering this herself, without my interference!

Is anyone considering switching from Immucor at this time based on the FDA letter? I am getting pressured to switch to Ortho since we already use gel.

Yes, I am considering switching, due to this issue, but mostly cost.

I don't think that you will find cost to be a major issue . . . the problem is that one vendor is unable to supply ALL the reagents that anyone needs. As far as I know, Immucor is the only supplier of Fetal Bleed screening kits. Unless you are going to go out and get a flow cytometer, there is not an alternative. Yes, you can get most of the rares at alternate vendors, but Ortho does not make a lot of the rare antisera so . . . I still think the feds won't pull their license . . .

Dear Brenda,

I felt sad when I read your comments. It is unfortunate that you perceive it to be tacky for another vendor to contact you to offer alternative reagent products as an option, if indeed, the FDA follows through on their statements in the NOIR letter, implements a consent decree and revokes Immucor's license to manufacture one or more of their reagent products. Perhaps this will not occur. Hopefully, for the sake of all involved, it won't.

However, there is always potential that it could - particularly since the FDA did this to Abbott back in 1999, once they knew there were sufficient other FDA-licensed, approved methods and vendors available to supply the market with the needed reagent alternatives. Vendors are people, too - just like you. They have lives and families to support -just like you. They have a job to do - just like you. Please respect them for doing it. If you don't want to have other vendor alternatives and are happy paying double the amount for your blood bank reagents year after year to Ortho and/or Immucor (or happy to ask your employer to do so), then okay - that's a choice you make and your right to make it. If your Lab Director supports you on that choice, great. Fortunately, not everyone in the blood banking world sees things as you do. Judge not lest thou be...

Mary Carpenter, B.S. MT(ASCP)

former Laboratory Director & Donor Testing Center Supervisor

Your comments seem a little strong to me. I am all for competition; it gives us choices and hopefully, more competitive prices. I do not object to a vendor contacting me about their products; I have worked with them for 26 years. It is the "way" they have approached me in this situation which I find to be in poor taste. That is my perception, which I think I should be allowed....

Brenda

As with others who have been in the laboratory field for more years than we would like to recall, this is eerily similar to Abbott. We received the same sort of conciliatory letter from them. How many Abbott products do we have in our lab today 15 years later? ZERO!

I miss the good old days where you could have 5 different panels in your refrigerator: Immucor, Ortho, Gamma, Dade and BCA. To have lost that competion (as well as selection) is unfortunate.

Brenda Hutson, CLS(ASCP)SBB

I'm with you, Brenda!!!

I used to solicit bids from the various BB vendors for our annual Blood Bank reagent contract, and it's incredible to look back on what a pittance we paid for reagents for an entire year. Just incredible! (Too bad that our salaries haven't followed the reagents' pace.)

There was a time there's 5 panels in the market?!

I only have Diamed and Immucor panels in my BB... Would like to have at least one more if I can help it...

I like the Medion DataCyte panel distributed by Olympus . . . always a Kpa+ cell and usually a Jsa+.

I just received the letter from Immucor regarding Using Buffered Saline with the Fetal Bleed Screening Test. We haven't been using phosphate-buffered saline. Since we use gel, we don't use a lot of saline. What is my best option for obtaining this product when I don't need a large volume? Thanks in advance.

There was a time there's 5 panels in the market?!

I only have Diamed and Immucor panels in my BB... Would like to have at least one more if I can help it...

Yes...clearly you are not an old-timer like me!

Brenda

I miss the good old days where you could have 5 different panels in your refrigerator: Immucor, Ortho, Gamma, Dade and BCA. To have lost that competion (as well as selection) is unfortunate.

Brenda Hutson, CLS(ASCP)SBB

Since you're bringing up the oldies, remeber Knickerbocker? Used to use it in NY

Since you're bringing up the oldies, remeber Knickerbocker? Used to use it in NY

Maybe not "that" old.....??

Brenda

Cardinal has buffered saline in smaller volumes - 4 and 10 L boxes. You might check with Fischer. If Cardinal has it, they probably do, too.

AMcCord: I can't find the 4L size in the buffered saline, just the regular saline. Do you have a catalog number for the 4L size from Cardinal? Thanks!

I hadn't looked at their stock list for a while - but after looking today, I only see 10 L and 20 L saline buffered. (I swear they used to carry buffered in the 4L size as well!) Fisher is the same story. Sorry the 4L size doesn't pan out.

Have you thought about getting a 4L unbuffered saline and adding the appropriate amount of pHix to get pH 7? Downside is validation and the hassle of adding the buffer and checking pH, plus buying the pHix. Might be cheaper to just buy the 10L size and dump some.

Is there anything special about the phosphate-buffered (approximately 15mM)? I use buffered saline at the pH they recommend but it says nothing on it about phosphate or mM.

I'm sure it will say something on the product insert.

And that is why I am not revising our procedure until I have the updated package insert in hand. I am afraid Immucor will add something else without prior notice. Of course, Hematology does the KB stains not Transfusion so I really am not feeling an urgent need to switch to buffered saline.

We send our positive fetal screens out for flow, instead of KB. This explains the negative flow results. We are also waiting to revise our procedure. I'm not too impressed with Immucor lately. I also remember the "good old days" when we had multiple options. Getting old isn't for the faint of heart.

... I also remember the "good old days" when we had multiple options. ...

It's a step back for the BB sector. =(