Z-1185-2024Class II

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

Name: Z-1185-2024 Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap
Creator: EMD Millipore Corporation
Published: 2024-01-26
License: https://open.fda.gov/license/

EMD Millipore Corporation / initiated 2024-01-26 / Open, Classified / root cause: manufacturing process

FDA source

EMD Millipore Corporation began a recall of Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap on 2024-01-26. FDA classified it as Class II and gives the reason as "This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1185-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-26
Posted: 2024-02-23
Recalling firm: EMD Millipore Corporation
Product: Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
Product code: HZT Reagent, Schiff
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: 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.
Quantity in commerce: 106 Units (25 US, 81 OUS)
Distribution: Domestic: AL, IL, MA, MN, NJ, PA, TX, VA. Foreign: Canada.
Product codes and lots: Part number: 6073-71, 500mL; Lot Numbers (Expiration Date): 3094 (2025-08-04), 3096 (2025-06-28);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1185-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1185-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-23

Product code HZT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)