Recall Z-0328-2022
Randox Laboratories Ltd. · initiated November 1, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Codes / lots: Lot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023. GTIN: 05055273201130
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
FDA-determined cause: Under Investigation by firm
Action taken
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 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 organisation. If you have any questions or concerns please contact Randox Technical Services.
Details
- Recall number
- Z-0328-2022
- Initiated
- November 1, 2021
- Terminated
- March 9, 2023
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Quantity
- 15 kits
- Distribution
- US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North