CRP Immunoturbidimetric reagent. Intended for the… recallZ-1286-2023 · Randox Laboratories · initiated Feb 1, 2023
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 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
The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range
FDA root cause category: Under Investigation by firm
What the company is doing
Randox UK (manufacturer) extended Urgent Medical Device Removal letter to the US distributor via email on 2/1/23. The distributor contacted the customer via email on 2/6/23. Letter states reason for recall, health risk and action to take: " Discontinue use of and discard any of the above immediately. Provide Randox with photographic evidence of the destruction of the kits. " 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. If you have any questions or concerns, please contact Randox Technical Services.
Recall details
- Recall number
- Z-1286-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 1, 2023
- Posted by the FDA
- Sep 30, 2024
- Recalling firm
- Randox Laboratories
- Quantity
- 2 kits
- Product code
- DCK
- FDA submissions
- K953212
- Distribution
- PA, OH, WV
Product description
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
Code information (models, lots, serial numbers)
GTIN: 05055273201765 Batch: 588434
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CRP CP3826Randox Laboratories Limited · C-Reactive Protein, Antigen, Antiserum, And Control1 recall0 reports
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.
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