VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.

Recall Insight

This FDA Devices action (record #Z-1714-2020) was formally reported on April 22, 2020, with the manufacturer initiating the action on March 12, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Greiner Bio-One North America, Inc. is listed as the recalling firm, operating out of Monroe, NC. Federal records indicate 1,000,800 units. 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: Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate. Distribution data in the federal record shows the product reached: US nationwide distribution in the states of: NJ, IN, TN, MI, NC, WA, KS, CA, LA, IL, MD, NY, OH, TX, GA, KY, PA, CO, MA, PR, FL, AR, OK and NE.. 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 6 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.