Recall Z-0412-2020
Randox Laboratories, Limited · initiated October 4, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Randox Liquid Cardiac Controls Catalogue Number CQ5051
Codes / lots: Catalogue Number: CQ5051 GTIN: 05055273207446 Batch/lot: 4243CK (Exp. 28Nov2019), 4246CK (Exp. 28Nov2019), 4249CK (Exp. 28Nov2019), 4260CK (Exp. 28Nov2019), 4311CK (Exp. 28May2020), 4317CK (Exp. 28May2020)
Reason for recall
Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ5051 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.
FDA-determined 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.
Details
- Recall number
- Z-0412-2020
- Initiated
- October 4, 2019
- Terminated
- July 6, 2020
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Quantity
- 6,208
- 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,
- Recalling firm
- Randox Laboratories, Limited, Crumlin
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0413-2020 Class II | 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… | 10/04/2019Terminated |
| Z-0414-2020 Class II | Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed… | 10/04/2019Terminated |