Cytocell recalls Aquarius LPH 511-A CRLF2 Distal Probe Green due to potential false lab test results. This may cause normal samples to be incorrectly reported as abnormal in certain tests.
Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a normal sample being reported as not normal in a resulting laboratory developed test (LDT) that utilizes the LPH511-A CRLF2 Distal Probe Green.
Cytocell is recalling its Aquarius LPH 511-A CRLF2 Distal Probe Green for possible false lab test results. This could lead to normal samples being incorrectly reported as abnormal in certain laboratory tests.
The probe may produce faint additional signals that cause laboratory tests to incorrectly report normal samples as abnormal. This is a low risk of false results in specific laboratory tests.
Lab technicians and healthcare providers who use this probe in laboratory tests may be affected. Those performing laboratory-developed tests with this probe are at the highest risk.
Look for the Aquarius LPH 511-A CRLF2 Distal Probe Green, model number LPH 511-A. The product was sold in lots 072240, 071390, and 072693.
Verify the lot number on the probe to see if it matches 072240, 071390, or 072693.
No, the recall is for a low risk of false test results, not a safety hazard.
Check the lot number to see if it matches 072240, 071390, or 072693. If it does, contact Cytocell for guidance.
The recall does not mention any injury risk; it only addresses potential false test results.
We’ve drafted a message you can send Cytocell to request your refund or repair — edit it as you like.
Subject: Recall Z-1099-2021 — Cytocell Cytocell Hello, I own a Cytocell that is covered by recall Z-1099-2021 from Cytocell. 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.
