Cytocell recalls Del(5q) FISH Probe Kit for incorrect color labeling that could lead to wrong results in AML/MDS chromosome testing. Affected kits have red and green probes swapped.
individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result
Cytocell recalls a lab test kit for detecting chromosome deletions in blood cancers. The kit's color labels are swapped, which could cause incorrect test results if used. This affects lab tests for AML and MDS patients.
The kit's probes are labeled with the wrong colors (red and green swapped). This causes the test to show 1G2R instead of the expected 1R2G pattern, leading to incorrect results for chromosome deletions.
Lab technicians and researchers using the Del(5q) FISH Probe Kit for AML or MDS testing. Patients receiving results from this kit may be at risk of incorrect diagnoses.
Check for the catalog number USA-LPH024 and lot number 075711. The kit expires June 22, 2023. The UDI code starts with (01)05055844901551(17)230622(10)075.
Verify the color labels on the probes; red should be for EGR1 and green for control.
The kit's probes have incorrect color labels (red and green swapped), which can cause wrong test results for chromosome deletions in AML or MDS patients.
The catalog number is USA-LPH024.
Look for the catalog number USA-LPH024 and lot number 075711 on the kit's packaging.
We’ve drafted a message you can send Cytoc:ell to request your refund or repair — edit it as you like.
Subject: Recall Z-0741-2022 — Cytoc:ell Cytoc:ell Hello, I own a Cytoc:ell that is covered by recall Z-0741-2022 from Cytoc:ell. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
