The Recall Desk

FDA (Devices) recall action 92586

Cytocell Ltd. recalled 2 products on 2023-07-26

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2023-07-26
Critical
0
Units
121

Why these products were recalled

DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2023-07-26

    RET Distal Probe Recalled Due to Manufacturing Defect in DNA Sequences

    FDA recalls RET Distal Probe due to manufacturing defect where DNA sequences used in production were inverted. The defect affects 61 units distributed in California, Florida, Ohio, and South Carolina and may impact diagnostic accuracy.

    Product
    RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2023-07-26

    FDA Recalls RET Proximal Probe Laboratory Diagnostic Kits for Inverted DNA

    Cytocell Ltd. RET Proximal Probe kits distributed to laboratories in California, Florida, Ohio, and South Carolina are being recalled due to inverted DNA sequences introduced during manufacturing.

    Product
    RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
    Category
    Distribution
    4 states