Unrated Medical device recall · FDA · Published February 1, 2024

Abbott M1000 Wash Station Assembly: Export-Only Product Shipped to U.S. Customers

Abbott Molecular recalls M1000 Wash Station Assembly & DITI Slide (REF 04J72-28) shipped to U.S. customers without U.S. approval. This export-only product may not meet U.S. specifications.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1190-2024Medical device Abbott Molecular ›

Recall notice

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.

Take action

Contact the company

Recalling firmAbbott Molecular, Inc.1300 E Touhy Ave · Des Plaines, IL 60018-3315

✎ GovInfoNow plain-language explainer

Abbott Molecular is recalling a wash station assembly and DITI slide part that was shipped to U.S. customers without proper U.S. approval. This export-only product may not meet U.S. specifications, but there is no stated risk of injury or harm. Read more at govinfonow.com/recall/56207-abbott-m1000-wash-station-assembly-export-only-product-shipped-to.

Source Summary by GovInfoNow · govinfonow.com/recall/56207-abbott-m1000-wash-station-assembly-export-only-product-shipped-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1190-2024

Cite this page

“Abbott M1000 Wash Station Assembly: Export-Only Product Shipped to U.S. Customers.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56207-abbott-m1000-wash-station-assembly-export-only-product-shipped-to. Based on FDA recall #Z-1190-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1190-2024%22&limit=1).

Abbott Molecular, Inc. recalled the M1000 Wash Station Assembly and DITI Slide because unapproved products intended for export were shipped to U.S. customers, according to the FDA. The Food and Drug Administration announced the Class III recall on Feb. 1, 2024.

How to tell if you have it

Brand: Abbott Molecular
Product: M1000 Wash Station Assembly & DITI Slide
REF: 04J72-28*
UDI-DI: 00884999006676

The hazard

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

Context

GovInfoNow's records show Abbott Molecular has issued 19 other recalls since Aug. 4, 2021. Recent brand recalls include an April 28, 2025 recall for false positive results risk and a March 20, 2025 recall for liquid spill hazards. Other recent recalls of similar products include Leaky Gut Test Product Recall (Nov. 3, 2025), GET TESTED International AB Liver Test Product Recall (Nov. 3, 2025), and MPOX Test Recall (Nov. 3, 2025).

How to tell if you have this one

Check for the part number REF 04J72-28 on the M1000 Wash Station Assembly or DITI Slide. The product was shipped to U.S. customers without U.S. approval and has no lot number or UDI-DI.

Brand
Abbott Molecular
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Ongoing
Distribution
US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.

Recall number	Product, codes & lots	Quantity
Z-1188-2024	In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;; (1) REF 01N15-010 - GTIN 00884999035362, Lot #381146, Exp. 2024-05-05; #381870, Exp. 2024-05-05; #382179 Exp. 2024-05-05; #387021, Exp. 2024-08-01; #528081, exp. 2023-11-16; (2) REF 01N34-020 - GTIN 00884999000766, Lot #522756, Exp. 2023-06-21.	16 kits
Z-1189-2024	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;; (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.	7 kits
Z-1190-2024	Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.); No lot number, UDI-DI 00884999006676.	—

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the part number REF 04J72-28 on the M1000 Wash Station Assembly or DITI Slide.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 8 states.

FDA distribution: “US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Illinois, Maryland, Massachusetts, Minnesota, New York, Pennsylvania.

Recall timeline

FDA published this recall 34 days after the firm started it.

Feb 1, 2024Firm started the recall
Feb 26, 2024FDA classified it Class III
Mar 6, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/56207-abbott-m1000-wash-station-assembly-export-only-product-shipped-to">Abbott M1000 Wash Station Assembly: Export-Only Product Shipped to U.S. Customers (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1190-2024 (February 1, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1190-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.