FDAFDA · Food and drugs·Recall number Z-2210-2023
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Published July 26, 2023 · Recall initiated: May 24, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cytocell Ltd.
- Distributor
- US Nationwide distribution in the states of CA, FL, OH, & SC.
- Lot
- Catalog No. LPS509-A; UDI-DI: 05055844900516; Lot No. 076764, 080124, 082129, 082560, 083247, 083550, 083850.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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