Burlington, MA, United States
EMD Millipore Corporation recalls
2 recalls recorded since 2018, most recently on 26 January 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 January 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1185-2024
- Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
Ongoing Class II Medical devices
- Recall started
- 17 October 2023
- Reason
- Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap and bottle. With an improper seal the Assay (current specification of 24.8 to 27.2 mL) is expected to continue to drop over time as iodine vapors continue to dissipate from the bottles.
- Distribution
- US States: CA, NJ, WV
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0408-2024
- Lugol s Iodine Solution 500ML, Part Number 624-71
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.