Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

VITROS Immunodiagnostic Products Signal Reagent Recalled by ORTHO-CLINICAL DIAGNOSTICS Due to The Immunodiagnostic Products Signal Reagent, Lot 3082 as...

Date: May 6, 2015
Company: ORTHO-CLINICAL DIAGNOSTICS
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ORTHO-CLINICAL DIAGNOSTICS directly.

Affected Products

VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.

Quantity: Domestic: 898 units

Why Was This Recalled?

The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ORTHO-CLINICAL DIAGNOSTICS

ORTHO-CLINICAL DIAGNOSTICS has 14 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report