VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266

Recall Insight

This FDA Devices action (record #Z-0058-2019) was formally reported on October 10, 2018, with the manufacturer initiating the action on July 12, 2018. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ortho Clinical Diagnostics Inc is listed as the recalling firm, operating out of Raritan, NJ. Federal records indicate 7880 units are affected.

The documented reason for this recall is: The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (I… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide distribution, and countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal,…. 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 8 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.