Device product
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
Z-1185-2024
Product summary
- Event
- Event 93890
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 106 Units (25 US, 81 OUS)
- Official record key
device-enforcement:Z-1185-2024
Official wording
Reason: This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.
Code information: Part number: 6073-71, 500mL; Lot Numbers (Expiration Date): 3094 (2025-08-04), 3096 (2025-06-28);
Distribution pattern: Domestic: AL, IL, MA, MN, NJ, PA, TX, VA. Foreign: Canada.
Derived failure modes
-
Unknown
This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.