Randox Liquid Cardiac Controls Catalogue Number CQ5052.
FDA Recall Z-0413-2020 · Posted None
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Recalling FirmRandox Laboratories, Limited
Recall StatusTerminated
Product CodeJJY
Date Initiated2019-10-04
Date Terminated2020-07-06
Product Quantity7,505
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.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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