FDA Medical Device Recalls (openFDA)
Randox Laboratories: CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
- Recall number
- Z-1286-2023
- Recalling firm
- Randox Laboratories
- Product
- CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
- Status
- Open, Classified
- Initiated
- 2023-02-01
- Posted
- 2024-09-30
- Terminated
- not on file
- Reason
- 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
- Root cause
- Under Investigation by firm
- Action
- 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 technical.services@randox.com within five working days. If you have any questions or concerns, please contact Randox Technical Services.
- Quantity
- 2 kits
- Distribution
- PA, OH, WV
- Lot, serial or model codes
- GTIN: 05055273201765 Batch: 588434
- 510(k) numbers
- ["K953212"]
- PMA numbers
- not on file
- Product code
- DCK
- Firm FEI
- 3003059701
- Firm city
- Kearneysville
- Firm state
- WV
- Firm country
- not on file
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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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