VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.

Recall Insight

This FDA Devices action (record #Z-0733-2024) was formally reported on January 24, 2024, with the manufacturer initiating the action on December 12, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Greiner Bio-One North America, Inc. is listed as the recalling firm, operating out of Monroe, NC. Federal records indicate 495,600 tubes units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glu… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA, TN, and VA.. 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 2 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.