Recall Z-2150-2019 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Randox Laboratories, Limited
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.
| Date | Jun 11, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 149 (US) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942458 | PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED Randox Laboratories, Ltd., Mar 13, 1995 |