Randox Liquid Cardiac Controls Catalogue Number CQ5052.
Recall
- Recall Number
- Z-0413-2020
- Event Number
- 84044
- Firm
- Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom
- FEI Number
- 1000361607
- Product Code
- JJY
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- October 4, 2019
- Terminated
- July 6, 2020
Description
Randox Liquid Cardiac Controls Catalogue Number CQ5052.
Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.
On October 1, 2019 the firm distributed Urgent Medical Device Recall letters by e-mail instructing them to: - Inspect your stock and quarantine affected stock. - Replace the value sheet in the kit with the revised value sheet provided. - Randox is not recommending a review of previous results as changes in quality control recovery would be reviewed at the time of occurrence. - Discuss the contents of this notice with your Medical Director. - Complete and return the response form 12187-QA to [email protected] within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization.
US Distribution: WV, CA, DE, NJ, NY, GA, IN, PR OUS Distribution: CA, PL, CH, JP, NL, IT, CN, GB, IE, RU, MD, BY, SA, VN, AE, BH, DK, CO, ES, FR, TW, PH, TH, OM, HU, IN, KR, ZA, AU, CZ, PE, CL, IR, NZ, BE, DE, BA, SV, SK, HK, PT, PK, BR, TR, UA, SE, QA, LT, PE,
7,505