Recall Z-1185-2024 ยท HZT Reagent, Schiff
EMD Millipore Corporation
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
| Date | Feb 23, 2024 (initiated Jan 26, 2024) |
| Status | Open, Classified |
| Reason | This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink. |
| 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 ide |
| Quantity | 106 Units (25 US, 81 OUS) |
| Distribution | Domestic: AL, IL, MA, MN, NJ, PA, TX, VA. Foreign: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.