Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
Summary
The FDA issued a Class II for Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a blac by EMD Millipore Corporation. Reason: This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink..
Details
Source
Device Recall
External ID
Z-1185-2024
Action Date
2024-03-06
Status
Ongoing
Category
device
Product Description
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
Lot/Code Info: Part number: 6073-71, 500mL; Lot Numbers (Expiration Date): 3094 (2025-08-04), 3096 (2025-06-28);
Quantity Affected: 106 Units (25 US, 81 OUS)
Reason for Recall
This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.
Distribution
Domestic: AL, IL, MA, MN, NJ, PA, TX, VA. Foreign: Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-26
Company
Burlington, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 205 device recalls issued in the same week, part of 403 device-related FDA actions this month.
EMD Millipore Corporation has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (EMD Millipore Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does EMD Millipore Corporation have FDA actions?
EMD Millipore Corporation has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1185-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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