FDA recall Z-1185-2024

EMD Millipore Corporation · Class II · device

Product

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

Domestic: AL, IL, MA, MN, NJ, PA, TX, VA. Foreign: Canada.

Key facts

Status
Ongoing
Initiation date
2024-01-26
Report date
2024-03-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Burlington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1185-2024