Cholestech LDX QC Backorder Alternatives and New Cassette Lot Failures

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Over the past few weeks, several sites have reported unexpected QC failures with the Cholestech LDX Glucose Cassette Lot #448526. If you’re running point‑of‑care testing, you know how disruptive this can be—especially when the current QC lot (902971491) isn’t passing, and the next QC lot is on backorder until mid‑April.
I’m trying to understand whether this is an isolated issue or something happening more broadly across the field, so I’m putting the questions out to the community.
1. Are other sites experiencing failures with Glucose Cassette Lot 448526?
Across my network, 7 sites using Lot 448526 are consistently failing QC with the current QC lot. Before assuming a cassette issue, I want to know whether others are seeing the same pattern.
If your site is using this lot, are you seeing similar QC failures?
2. What alternative QC strategies are other sites using?
With the next QC lot unavailable until mid‑April, many of us need a temporary workaround to keep testing operational.
My current plan is to create an in‑house pooled QC:
  • Prepare low and high pooled patient samples
  • Run 20 data points for each level
  • Calculate the mean
  • Establish a ±2 SD range to use as temporary QC limits
This approach is valid in principle, but I’m curious what others are doing. Are you creating pooled QC? Using another validated method? Temporarily suspending glucose testing?
Share Your Experience
If your site is dealing with Lot 448526—or if you’ve found a reliable alternative QC strategy—your insight could help a lot of labs navigate this shortage more smoothly.
What’s working for you, and what challenges are you running into?

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We are experiencing this issue with cassette lot 447122 and 442464, QC lot 902973640. We are experiencing QC failures with Glucose specifically. I have reported the issue to Abbott and have not heard back yet. In the meantime, we will not be offering this testing. 

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