Randox Laboratories: Medical Device Recall in 2023 - (Recall #: Z-1286-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826

Product Classification:

Class II

Date Initiated: February 1, 2023

Date Posted: April 5, 2023

Recall Number: Z-1286-2023

Event ID: 91745

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

Status: Ongoing

Product Quantity: 2 kits

Code Information:

GTIN: 05055273201765 Batch: 588434

Distribution Pattern:

PA, OH, WV

Voluntary or Mandated:

Voluntary: Firm initiated