CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.

Recall Insight

This FDA Devices action (record #Z-1545-2014) was formally reported on May 14, 2014, with the manufacturer initiating the action on February 26, 2013. It is classified under Low severity (Class III), with a current status of Terminated. Siemens Healthcare Diagnostics Inc is listed as the recalling firm, operating out of Norwood, MA. Federal records indicate 1 unit units are affected.

The documented reason for this recall is: Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. Distribution data in the federal record shows the product reached: US Distribution in the state of: CA.. 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 12 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.