Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-1190-2024·Announced 2024-03-06

Abbott M1000 Wash Station Shipped Without U.S. Approval or Registration

Abbott Molecular recalled M1000 Wash Station units shipped to U.S. customers without FDA approval or registration. The devices were intended for export only and not approved for U.S. distribution.

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 involving regulatory non-compliance rather than reported patient harm. The devices were shipped without proper U.S. approval or registration, but no illnesses, injuries, or deaths have been reported. Per the rubric, FDA Class III recalls are typically scored 1 or 2.

Plain-English summary

Abbott Molecular, Inc. recalled its M1000 Wash Station Assembly and DITI Slide (REF 04J72-28) because units intended for export only were mistakenly shipped to U.S. customers. These devices were not approved or registered in accordance with U.S. specifications required for domestic distribution.

The affected wash stations were distributed nationwide to locations in Alabama, California, Illinois, Massachusetts, Maryland, Minnesota, New York, and Pennsylvania. The device is identified by UDI-DI 00884999006676. No lot numbers have been specified for this recall.

If you have received or are operating this wash station, contact Abbott Molecular, Inc. to determine if your unit is affected and to arrange for return or replacement with a device that meets U.S. approval and registration requirements.

The recalled product

Product: Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
Manufacturer: Abbott Molecular, Inc.
Category: Medical Device — Laboratory Equipment
Hazard: regulatory-non-compliance
unapproved-device

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 (2)

No lot number
UDI-DI 00884999006676.

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

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.

See all 3 products in this recall →

Same manufacturer · Abbott Molecular, Inc.

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