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;

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.

Recall #: Z-1189-2024
Affected scope: 7 kits
Initiated: February 1, 2024

Compiled from official public sources by the publisher. · Updated September 2026

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Abbott Molecular, Inc. recalled In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF … - a low-severity action.

In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF … was recalled by Abbott Molecular, Inc. in March 6, 2024. Reason: Products that were intended for export only which were not approved or registered in accordance with U.S. spe…. Check the official notice for the remedy. Verify recall #Z-1189-2024 with the FDA Devices before acting.

The recall

Abbott Molecular, Inc. issued this low-severity FDA Devices recall-Products that were intended for export only which were not approved or registered in accordance with U.S. spe….

Low
severity level: Class III
classification: March 6, 2024
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1189-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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;

Reason for recall

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Low (Class III)
Status	Ongoing
Recall number	Z-1189-2024
Date reported	March 6, 2024
Date initiated	February 1, 2024
Recalling firm	Abbott Molecular, Inc.
Firm location	Des Plaines, IL
Affected scope	7 kits
Distribution	US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1189-2024) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

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.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 6, 2024. Severity: Low. Recall number: Z-1189-2024.

Where was the recalled product distributed? ▼

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

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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This recall: FDA Devices, reported March 6, 2024. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026