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Recall Observatory FDA recall evidence

Device product

In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J03-001; (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe, REF 05J03-004; (5) Abbott Vysis TelVysion 22q SpectrumOrange Probe, REF 05J04-022;

Z-1189-2024

February 01, 2024

Class III

Product summary

Firm
Abbott Molecular, Inc.
Event
Event 93902
Status
Ongoing
Classification
Class III
Quantity
7 kits
Official record key
device-enforcement:Z-1189-2024

Official wording

Reason: Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.

Code information: (1) REF 01N33-020 - GTIN 00884999000759, Lot #381411, Exp. 2024-09-22; (2) REF 04N62-020 - GTIN 00884999009301, Lot #382133, Exp. 2024-05-25; (3) REF 05J03-001 - GTIN 00884999009882, Lot #381111, Exp. 2024-06-17; (4) REF 05J03-004 - GTIN 00884999009912, Lot #381102, Exp. 2024-06-17; (5) REF 05J04-022 - GTIN 00884999010451, Lot #530242, Exp. 2024-03-28.

Distribution pattern: US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.