The Recall Desk
HighFDA (Devices)·Z-2209-2023·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a diagnostic probe with manufacturing defects affecting test function. Classified as 'High' under the rubric as a risk-of-harm product (inverted DNA could compromise test accuracy) with no reported illnesses or injuries.

Plain-English summary

The FDA is recalling RET Proximal Probe laboratory diagnostic kits manufactured by Cytocell Ltd. The affected product contains DNA probes with inverted DNA sequences that were introduced during manufacturing. These probes are used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating specific DNA sequences on chromosomes.

Sixty units of the affected product were distributed nationwide to laboratories in California, Florida, Ohio, and South Carolina. The affected lot numbers are 076763, 077253, 080125, 080763, 082128, 083041, 083246, and 083555 (Catalog No. LPS508-A; UDI-DI: 05055844900509).

Cytocell Ltd. is recalling the product due to the manufacturing defect. Laboratories that have received the affected product should contact the manufacturer to determine whether the product was used and determine appropriate next steps.

The recalled product

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.
Manufacturer
Cytocell Ltd.
Category
Medical Device — Laboratory Diagnostic Probe
Hazard
Affected units
60

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • Catalog No. LPS508-A
  • UDI-DI: 05055844900509
  • Lot No. 076763
  • 077253
  • 080125
  • 080763
  • 082128
  • 083041
  • 083246
  • 083555.

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Cytocell Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Cytocell Ltd.

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