CLASS III Device recall · Reported 27 Apr 2016 · FDA Enforcement Report
Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit recalled
Biocare Medical is recalling Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit, distributed nationwide in the US. The recall was initiated on 31 Mar 2016 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1523-2016
- FDA event ID
- 73752
- Recalling firm
- Biocare Medical, Concord, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 31 Mar 2016
- FDA classified
- 19 Apr 2016
- Reported
- 27 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Test Kits & Diagnostics
Timeline
| 31 Mar 2016 | Recall initiated by company | |
| 19 Apr 2016 | Classified by FDA | +19 days |
| 27 Apr 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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
Nationwide ArizonaCaliforniaColoradoFloridaGeorgiaIllinoisKansasKentuckyMassachusettsMissouriNorth CarolinaNew YorkOklahomaOregonPennsylvaniaSouth CarolinaTennesseeTexas
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot number 082715; Expiry 01/2017.
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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