FDA Enforcement
Class II
Ongoing
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
Recall: Z-1185-2024
·
Reported March 6, 2024
Enforcement
- Recall Number
- Z-1185-2024
- Event ID
- 93890
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- EMD Millipore Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 6, 2024
- Initiation Date
- January 26, 2024
- Classification Date
- February 23, 2024
- Address
- 400 Summit Dr, Burlington, MA, 01803-5258, United States
Description
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
Reason
This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.
Code Info
Part number: 6073-71, 500mL; Lot Numbers (Expiration Date): 3094 (2025-08-04), 3096 (2025-06-28);
Distribution
Domestic: AL, IL, MA, MN, NJ, PA, TX, VA. Foreign: Canada.
Quantity
106 Units (25 US, 81 OUS)