Abbott Vysis Diagnostic Kits Recalled for U.S. Regulatory Non-Compliance
Abbott Molecular recalls five Vysis in-vitro diagnostic kits that were intended for export and shipped to U.S. customers without approval or registration per U.S. specifications.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall of diagnostic kits shipped without U.S. approval or registration. No illnesses, injuries, or product defects are reported; per the rubric, Class III recalls are typically scored 1–2, and the regulatory non-compliance hazard supports a Moderate classification.
Plain-English summary
Abbott Molecular is recalling five types of Vysis in-vitro diagnostic kits (FISH probes for genetic testing) that were shipped to U.S. customers without U.S. approval or registration. These products were intended for export only and do not meet U.S. specifications.
The affected kits include the Abbott Vysis LSI ATM (11q22.3) SpectrumOrange Probe (REF 01N33-020), Abbott Vysis PTEN/CEP 10 FISH Probe Kit (REF 04N62-020), Abbott Vysis TelVysion 1p SpectrumGreen Probe (REF 05J03-001), Abbott Vysis TelVysion 4P SpectrumGreen Probe (REF 05J03-004), and Abbott Vysis TelVysion 22q SpectrumOrange Probe (REF 05J04-022). These kits were distributed nationwide in Alabama, California, Illinois, Massachusetts, Maryland, Minnesota, New York, and Pennsylvania.
Customers who have received these products should stop using them and contact Abbott Molecular for instructions on returning the kits or obtaining replacement products that comply with U.S. specifications.
The recalled product
- 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…
- Manufacturer
- Abbott Molecular, Inc.
- Category
- Medical Device
- Affected units
- 7
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 (14)
- (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
- (5) REF 05J04-022 - GTIN 00884999010451
- Lot #530242
- Exp. 2024-03-28.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Abbott Molecular, Inc. 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.
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