Date Initiated by Firm |
June 11, 2019 |
Create Date |
August 06, 2019 |
Recall Status1 |
Terminated 3 on May 15, 2020 |
Recall Number |
Z-2150-2019 |
Recall Event ID |
83155 |
510(K)Number |
K942458
|
Product Classification |
Multi-analyte controls, all kinds (assayed) - Product Code JJY
|
Product |
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. |
Code Information |
1306UN, 1308UN, 1309UN |
Recalling Firm/ Manufacturer |
Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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 in Commerce |
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. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JJY and Original Applicant = RANDOX LABORATORIES, LTD.
|