Recall archive / FDA device enforcement
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap. — FDA record Z-1185-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 26, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
- Reason
- This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.
- Classification
- Class II
- Recalling firm
- EMD Millipore Corporation
- Quantity
- 106 Units (25 US, 81 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1185-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Part number: 6073-71, 500mL; Lot Numbers (Expiration Date): 3094 (2025-08-04), 3096 (2025-06-28); |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: AL, IL, MA, MN, NJ, PA, TX, VA. Foreign: Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 6, 2024
- Recall initiation date
- Jan 26, 2024
- Center classification date
- Feb 23, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.