Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
This recall has been terminated (originally issued June 11, 2019).
- Recall Initiated
- June 11, 2019
- Terminated
- May 15, 2020
- Recall Number
- Z-2150-2019
- Quantity
- 149 (US)
- Official Source
- View on FDA website ↗
Reason for Recall
The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.
Distribution
US Nationwide Distribution - AZ CA CT FL GA IL KY LA MA MD MI MN MO NJ NY OH OK OR PA TX UT VA WA WI WV and PR. Worldwide foreign distribution.
Lot / Code Info
1306UN, 1308UN, 1309UN
Root Cause
Under Investigation by firm
Action Taken
On May 25, 2019, the firm notified its customers of the recall via Urgent Medical Device Correction letters. Customers were instructed to do the following: " Review your reagent inventory of these products. Remove all previous versions of the Value Sheets in use and replace with the revised version. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to t echnical.services@ randox.com within five working days. If you have any questions or concerns, please contact Randox Technical Services.