Z-1286-2023Class II

CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in...

Name: Z-1286-2023 CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in...
Creator: Randox Laboratories
Published: 2023-02-01
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2023-02-01 / Open, Classified

FDA source

Randox Laboratories began a recall of CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826 on 2023-02-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1286-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-01
Posted: 2024-09-30
Recalling firm: Randox Laboratories, Limited
Product: CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
Product code: DCK C-Reactive Protein, Antigen, Antiserum, And Control
Reason for recall: 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: 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 [email protected] within five working days. If you have any questions or concerns, please contact Randox Technical Services.
Quantity in commerce: 2 kits
Distribution: PA, OH, WV
Product codes and lots: GTIN: 05055273201765 Batch: 588434

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1286-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1286-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-24

Product code DCK

K953212Class IIC-Reactive Protein Immunoturbidimetric Kit & Crp CalibratorRandox Laboratories, Ltd. / cleared 1995-07-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)