VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.

Recall Insight

This FDA Devices action (record #Z-1804-2014) was formally reported on June 25, 2014, with the manufacturer initiating the action on May 12, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Ortho-Clinical Diagnostics is listed as the recalling firm, operating out of Rochester, NY. Federal records indicate Domestic - 612 units, Foreign - 461 units units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete pr… Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and …. 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 12 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.