Randox Liquid Cardiac Controls Catalogue Number CQ5052.
This recall has been terminated (originally issued October 4, 2019).
- Recall Initiated
- October 4, 2019
- Terminated
- July 6, 2020
- Recall Number
- Z-0413-2020
- Quantity
- 7,505
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
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,
Lot / Code Info
Catalogue Number: CQ5052 GTIN: 05055273207453 Batch/lot: 4244CK (Exp. 28Nov2019), 4247CK (Exp. 28Nov2019), 4261CK (Exp. 28Nov2019), 4312CK Exp. 28Jun2020) and 4315CK (Exp. 28Jun2020)
Root Cause
Under Investigation by firm
Action Taken
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 technical.services@randox.com 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.