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Recall Observatory FDA recall evidence

Device 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.

Z-2210-2023

May 24, 2023

Class II

Product summary

Firm
Cytocell Ltd.
Event
Event 92586
Status
Ongoing
Classification
Class II
Quantity
61 units
Official record key
device-enforcement:Z-2210-2023

Official wording

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

Code information: Catalog No. LPS509-A; UDI-DI: 05055844900516; Lot No. 076764, 080124, 082129, 082560, 083247, 083550, 083850.

Distribution pattern: US Nationwide distribution in the states of CA, FL, OH, & SC.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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