[Recalled] 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
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | 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 antib |
|---|---|
| Brand / manufacturer | Biocare Medical, LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1523-2016 |
| Country of notice | United States |
| Risk level | Class III |
| Hazard type | recall |
| Notice date | 31 March 2016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class III recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Biocare Medical, LLC
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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