EMD Millipore Issues Recall of Schiff Reagent Hotchkiss-McManus for Discoloration
EMD Millipore has recalled Schiff Reagent Hotchkiss-McManus (lots 3094 and 3096) because units appear pink instead of colorless. Laboratories should discontinue use of affected units distributed to US states and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with confirmed visual specification deviation (colorless versus pink product appearance) and inventory-wide impact, but no reported functionality failures or patient harm. No illnesses or injuries documented.
Plain-English summary
EMD Millipore Corporation has recalled Schiff Reagent Hotchkiss-McManus (Part number 6073-71, 500mL). The reagent is specified to be colorless, but some units appear pink instead. The discoloration was discovered after a customer complaint, and the company confirmed the issue affected additional units in inventory.
The affected lots are: Lot 3094 (expiration date August 4, 2025) and Lot 3096 (expiration date June 28, 2025). A total of 106 units were involved: 25 distributed in the United States (Alabama, Illinois, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, and Virginia) and 81 distributed internationally to Canada.
Laboratory users with these lot numbers should discontinue use of the affected reagent. Further guidance should be sought from EMD Millipore Corporation regarding replacement or alternative testing procedures.
The recalled product
- Product
- Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
- Manufacturer
- EMD Millipore Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Part number: 6073-71
- 500mL
- Lot Numbers (Expiration Date): 3094 (2025-08-04)
- 3096 (2025-06-28)
Distribution
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