Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.

Recall Insight

This FDA Devices action (record #Z-1256-2019) was formally reported on May 8, 2019, with the manufacturer initiating the action on January 11, 2019. It is classified under Low severity (Class III), with a current status of Terminated. Lin-Zhi International Inc is listed as the recalling firm, operating out of Santa Clara, CA. Federal records indicate 49 kits units are affected.

The documented reason for this recall is: Shelf life of the product may be reduced due to degradation of the assay. Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of CA, MA, GA, KY, NC, MI, MD, NC, CT, AZ SC, TN, OR. 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 7 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.