VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883 inclusive; IVD --- Ortho-Clinical Diagnostics For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate the VITROS 5,1 FS Chemistry System, the VIT

Recall Insight

This FDA Devices action (record #Z-2119-2016) was formally reported on July 13, 2016, with the manufacturer initiating the action on May 24, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Ortho-Clinical Diagnostics is listed as the recalling firm, operating out of Rochester, NY. Federal records indicate US: 1517; Foreign: 842 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: Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned t… Distribution data in the federal record shows the product reached: Worldwide Distribution - US (Nationwide, Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland, a…. 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 10 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.