FDA Device recall Z-1523-2016
Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit
- FDA Device
- Class III
- terminated
- Published 2016-04-27
On 2016-04-27 the FDA classified a Class III recall of Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit by Biocare Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1523-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-03-31 |
| Published | 2016-04-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biocare Medical |
| Distribution | US |
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 antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
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.
Identifiers
| code_info | Lot number 082715; Expiry 01/2017. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1523-2016%22
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