DxM 1040 MicroScan WalkAway Instrument REF B1018-440

Recall Insight

This FDA Devices action (record #Z-1085-2022) was formally reported on May 25, 2022, with the manufacturer initiating the action on October 21, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Beckman Coulter Inc. is listed as the recalling firm, operating out of Brea, CA. Federal records indicate 40 systems units are affected.

The documented reason for this recall is: WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere Distribution data in the federal record shows the product reached: Worldwide distribution - U.S. Nationwide distribution in the states of Alaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.