Recall Z-1547-2020 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Randox Laboratories Ltd.
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.
| Date | Feb 18, 2020 |
| Status | Open, Classified |
| Reason | The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly. |
| Root cause | Under Investigation by firm |
| Action | On February 18, 2020, the firm notified customers of the action via emailed Urgent Medical Device Correction letters. Customers were informed of the incorrectly assigned control target and range value for Sodium using the ISE indirect method. The letter stated that the sections for Roche Cobas series and mean of all instruments has now been updated, and the updated value sheets were included with the email. The updated value sheets may also be found on www.randox.com. Customers were asked to take the following actions: - Review results generated with the affected batches in line with the cli |
| Quantity | 186 total, 27 USA |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of WV, IN, VA, ID, PR, DE, and countries of West Indies, Czech Republic, France, Germany, Hong Kong, Ireland, Italy, Norway, Philippines, South Africa, South Korea, Sweden, Taiwan (R.O.C.), Thailand, UAE, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140971 | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. Randox Laboratories Limited, Dec 8, 2014 |