Lp (a) recallZ-1017-2025 · Randox Laboratories, Limited · initiated Dec 20, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Randox Laboratories, Limited or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
FDA root cause category: No Marketing Application
What the company is doing
Randox Laboratories Ltd (manufacturer) extended recall to the distribution center in the USA via email on 12/20/24. The distributor will then contact the customer directly via email. Letter states reason for recall, health risk and action to take: Action to be taken: " Discontinue use of and discard any copies of Roche Cobas c501 ISA listing nmol/1 claims. " Ensure clinical results are no longer reported in nmol/1 using the Roche Cobas c501 nmol/1 claims. " 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.
Recall details
- Recall number
- Z-1017-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 20, 2024
- Posted by the FDA
- Jan 23, 2025
- Recalling firm
- Randox Laboratories, Limited
- Quantity
- 15 kits
- Product code
- DFC
- FDA submissions
- K011568
- Distribution
- US Nationwide distribution Including PR.
Product description
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Code information (models, lots, serial numbers)
UDI-DI: 05055273204421 All lots within expiry
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Lp (a) LP3403Randox Laboratories Limited · Lipoprotein, Low-Density, Antigen, Antiserum, Control1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K011568 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Lp (a) LP2757Randox Laboratories Limited · Lipoprotein, Low-Density, Antigen, Antiserum, Control1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96043).
- Z-1018-2025 · Open, ClassifiedRandox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page