EMD Millipore Corporation: Schiff Reagent Recalled Due to Discoloration and Potential Instability

Agency Publication Date: February 23, 2024

Summary

EMD Millipore Corporation is recalling 106 units of Schiff Reagent (Hotchkiss-McManus), an in-vitro diagnostic (IVD) solution used in laboratory testing. The recall was initiated after a customer reported the normally colorless liquid appeared pink, which was later confirmed in additional inventory. This discoloration indicates the chemical reagent may not perform as intended, potentially leading to inaccurate diagnostic results.

Risk

The pink discoloration suggests the reagent has reacted or degraded, which can compromise the accuracy of laboratory staining and medical diagnoses. While no injuries have been reported, using unstable reagents can lead to false-negative or false-positive medical test results.

What You Should Do

Identify your product by checking the label for Part Number 6073-71 (500mL size) packaged in amber glass bottles with black polypropylene caps.
Check your specific lot numbers and expiration dates: Look for Lot 3094 with an expiration date of 2025-08-04, or Lot 3096 with an expiration date of 2025-06-28.
Visually inspect the solution; although the reagent should be colorless, any bottle from these affected lots should be removed from use regardless of its current appearance.
Stop using the affected reagent immediately and contact your healthcare provider or EMD Millipore Corporation to discuss the impact on any previous diagnostic tests and to arrange for disposal or replacement.
Contact EMD Millipore Corporation directly at their Burlington, Massachusetts headquarters or through your primary sales representative for further instructions regarding affected stock.
For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Schiff Reagent, Hotchkiss-McManus (500mL)

Model / REF:

6073-71

Lot Numbers:

3094 (Exp 2025-08-04)

3096 (Exp 2025-06-28)

Date Ranges: 2025-08-04, 2025-06-28

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93890

Status: Active

Manufacturer: EMD Millipore Corporation

Sold By: EMD Millipore Corporation; Laboratory suppliers

Manufactured In: United States

Units Affected: 106 Units (25 US, 81 OUS)

Distributed To: Alabama, Illinois, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify your product by checking the label for Part Number 6073-71 (500mL size) packaged in amber glass bottles with black polypropylene caps.

Check your specific lot numbers and expiration dates: Look for Lot 3094 with an expiration date of 2025-08-04, or Lot 3096 with an expiration date of 2025-06-28.

Visually inspect the solution; although the reagent should be colorless, any bottle from these affected lots should be removed from use regardless of its current appearance.

Stop using the affected reagent immediately and contact your healthcare provider or EMD Millipore Corporation to discuss the impact on any previous diagnostic tests and to arrange for disposal or replacement.

Contact EMD Millipore Corporation directly at their Burlington, Massachusetts headquarters or through your primary sales representative for further instructions regarding affected stock.

For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.