The Recall Desk
HighFDA (Devices)·Z-2576-2021·Announced 2021-10-06

Vysis CLL FISH Probe Kit may fail to detect genetic deletion

Abbott is recalling Vysis CLL FISH Probe Kits that may not detect 13q deletions in patient samples. This could lead to missed diagnosis of a genetic abnormality used in cancer treatment planning.

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: This is an FDA Class II recall of a diagnostic device with potential for false-negative results that could lead to missed detection of an important genetic abnormality. Although no illnesses or injuries have been reported, the hazard represents a risk-of-harm product where diagnostic failure has not yet caused reported patient harm.

Plain-English summary

Abbott Molecular, Inc. is recalling the Vysis CLL FISH Probe Kit, a laboratory diagnostic tool used to detect genetic abnormalities in chronic lymphocytic leukemia (CLL) patients. The kit applies fluorescence in situ hybridization (FISH) technology to identify genetic markers that inform cancer treatment decisions.

The affected kits may fail to detect the 13q deletion, a genetic abnormality that is actually present in patient samples. This test failure could result in missed identification of this important prognostic marker used in cancer treatment planning.

Approximately 186 units have been distributed worldwide, including across the United States and internationally.

Healthcare providers and laboratories should stop using the affected kits and contact Abbott Molecular, Inc. for replacement units and further instructions.

The recalled product

Product
Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes
Manufacturer
Abbott Molecular, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
  • diagnostic-failure
  • false-negative

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 (9)

  • UDI: (01)00884999042780(10)XXXXX(17)211015(240)04N02-021
  • US Distribution: Part Number 04N02-021
  • Lot Numbers 517086
  • 518656
  • International Distribution: List/Part Numbers (Lot Number): 04N02-021 (517086
  • 518656)
  • 04N02-022 (517516
  • 519303)
  • 05J83-001/Part 32-191025 (517068).

Distribution

Distributed nationwide across the United States.

Related recalls

Same category