RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
FDA Recall Z-0328-2022 · Posted None
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Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeCHH
Date Initiated2021-11-01
Date Terminated2023-03-09
Product Quantity15 kits
Reason for Recall
When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range
Firm Action
Randox USA, Distributor contacted the customer via Urgent Medical Device Correction letter email on 11/1/21. The letter states reason for recall, health risk and action to take:
Action to be taken:
" Discontinue use of and discard any of the above batches immediately.
" Review your reagent inventory of these products and assess your laboratories needs
for reimbursement for discarded inventory.
" Review results generated with the affected batches in line with the clinical profile of
the patient.
" 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 organisation.
If you have any questions or concerns please contact Randox Technical Services.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.
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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