Recall Z-1523-2016 ยท NJT Immunohistochemistry Reagents And Kits
Biocare Medical, LLC
Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. Th
| Date | Mar 31, 2016 |
| Status | Terminated |
| Reason | Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some few Mach 4 Mouse Probe vials may have been mislabeled as HRP-Polymer. |
| Root cause | Labeling mix-ups |
| Action | Biocare Medical sent a Medical Device Recall Notification letter dated March 31, 2016 to affected US customers by USPS. Foreign consignees were also notified per their various government regulations. The letter identified the affected product, problem and actions to be taken. Customers were requested to complete and return by April 15, 2016 the enclosed Return Response Form. |
| Quantity | 93 |
| Distribution | US Nationwide Distribution in the states of: KS, CA, AZ, OR, FL, KS, CO, MA, KY, NY, IL, OR, MO, NC, TX, PA, OK. SC, TN, PA, TN, GA, and OR. Hungary, Canada, Boliva |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.