Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit — Class III medical device recall Z-1523-2016
Terminated recall by Biocare Medical, LLC, reported 2016-04-27, distributed nationwide. Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some few Mach 4 Mo
| Recall number | Z-1523-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocare Medical, LLC, Concord, CA, United States |
| Recall initiated | 2016-03-31 |
| Classified | 2016-04-19 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2016-06-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, HU |
| Quantity | 93 |
| Reason classes | labeling |
| Lot numbers | 082715 |
| Model numbers | M4U534L |
| Expiration dates | 2017-01 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1523-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.