Recall Z-1286-2023— Randox Laboratories

Name: FDA recall Z-1286-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-01

Class II · Ongoing

Class II FDA medical device recall by Randox Laboratories, initiated 2023-02-01. It names one FDA 510(k) clearance: K953212. Product: CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826. 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.

Recalling firm: Randox Laboratories
Classification: Class II
Status: Ongoing
Initiated: 2023-02-01
Firm location: Kearneysville, WV, United States

510(k) clearances named in this recall

1 on FDA's record

K953212 — C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATORRandox Laboratories, Ltd.·cleared 1995-07-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.