Z-1185-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2024
- Initiation Date
- January 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 106 Units (25 US, 81 OUS)
Product Description
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
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 Pattern
Domestic: AL, IL, MA, MN, NJ, PA, TX, VA. Foreign: Canada.
Code Information
Part number: 6073-71, 500mL; Lot Numbers (Expiration Date): 3094 (2025-08-04), 3096 (2025-06-28);