FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
- Recall number
- Z-0328-2022
- Recalling firm
- Randox Laboratories Ltd.
- Product
- RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
- Status
- Terminated
- Initiated
- 2021-11-01
- Posted
- not on file
- Terminated
- 2023-03-09
- Reason
- 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
- Root cause
- Under Investigation by 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 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.
- Quantity
- 15 kits
- Distribution
- US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.
- Lot, serial or model codes
- Lot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023. GTIN: 05055273201130
- 510(k) numbers
- ["K923504"]
- PMA numbers
- not on file
- Product code
- CHH
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- North
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28