Santa Clara, CA, United States
Lin-Zhi International Inc recalls
1 recall recorded since 2018, most recently on 11 January 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 11 January 2019
- Terminated
- 22 March 2021
- Reason
- Shelf life of the product may be reduced due to degradation of the assay.
- Distribution
- US Nationwide Distribution in the states of CA, MA, GA, KY, NC, MI, MD, NC, CT, AZ SC, TN, OR
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1256-2019
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.