Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

Recall Insight

This FDA Devices action (record #Z-1857-2021) was formally reported on June 23, 2021, with the manufacturer initiating the action on April 14, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Radiometer Medical ApS is listed as the recalling firm, operating out of Bronshoj. Federal records indicate Total=4,135 analyzers world-wide (only 1277 analyzers within the U.S.) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. Distribution data in the federal record shows the product reached: Worldwide distribution - U.S. Nationwide distribution in the states of AK, A L, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR,…. 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 5 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.