Z-1523-2016Class III

Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use...

Name: Z-1523-2016 Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use...
Creator: Biocare Medical, LLC
Published: 2016-03-31
License: https://open.fda.gov/license/

Biocare Medical LLC / initiated 2016-03-31 / Terminated / root cause: labeling and UDI

FDA source

Biocare Medical, LLC began a recall of 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... on 2016-03-31. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1523-2016
Classification: Class III
Status: Terminated
Initiated: 2016-03-31
Posted: 2016-04-19
Terminated: 2016-06-20
Recalling firm: Biocare Medical LLC
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.
Product code: NJT Immunohistochemistry Reagents And Kits
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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
Product codes and lots: Lot number 082715; Expiry 01/2017.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1523-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1523-2016	Class III	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-19

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)