Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.

Recall Insight

This FDA Devices action (record #Z-0933-2022) was formally reported on April 20, 2022, with the manufacturer initiating the action on March 8, 2022. It is classified under Moderate severity (Class II), with a current status of Terminated. MEDLINE INDUSTRIES, LP - Northfield is listed as the recalling firm, operating out of Northfield, IL. Federal records indicate 10 boxes units are affected.

The documented reason for this recall is: The product was stored incorrectly due to improper storage controls which may lead to delayed results. Distribution data in the federal record shows the product reached: Distribution was made to AL, FL, NE OH, TX, WA, and WI. There was no foreign/military/government distribution.. 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.