Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.

FDA device recall Z-1185-2024 · posted 2024-02-23 · Open, Classified

Recall details

Recalling firm

EMD Millipore Corporation

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.

Action taken

An URGENT MEDICAL DEVICE RECALL NOTIFICATION LETTER, DATED 26 January 2024 was sent to customers. Required/Recommended Action Please immediately examine your inventory to determine if you have any remaining impacted product and forward a copy of this letter to the personnel in your organization that utilize this product and/or need to be made aware of this issue. Please discard this material and request a refund. Please complete attachment 1 form acknowledging receipt of this letter and return to the noted email address. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this issue. Your notification to customers should include a copy of this notification. You may contact Technical or Customer Service to discuss an appropriate solution for your needs at 1-800-221-1975 or 1-800-325-3010 or 1-800-645-5476. If you would like more information about this customer notification, please contact your local representative or use the link www.sigmaaldrich.com/offices for our website to obtain the phone number and/or email address of your local office.

Root cause

Material/Component Contamination

Status

Open, Classified

Product code

HZT

Quantity affected

106 Units (25 US, 81 OUS)

Distribution

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

Date initiated

2024-01-26

Date posted

2024-02-23

Location

Burlington, MA