---
title: "CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro deter... — FDA record Z-1286-2023 | Is It on Recall"
description: "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 wit"
url: https://isitonrecall.com/recall/fda-device-z-1286-2023-crp-immunoturbidimetric-reagent-intended-for-the-quantitative-in-vitro-determination-of-crp-concentr/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum C... — FDA record Z-1286-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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
- **Classification**: Class II
- **Recalling firm**: Randox Laboratories
- **Quantity**: 2 kits
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1286-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1286-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | GTIN: 05055273201765 Batch: 588434 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

PA, OH, WV

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Ohio](https://isitonrecall.com/state/ohio/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [West Virginia](https://isitonrecall.com/state/west-virginia/)

## Dates in the source

- **Report date**: Apr 5, 2023
- **Recall initiation date**: Feb 1, 2023
- **Center classification date**: Mar 24, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1286-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Randox Laboratories records](https://isitonrecall.com/brand/randox-laboratories/)