CLASS II Device recall · Reported 1 Jun 2016 · FDA Enforcement Report
Novocastra Liquid Mouse Monoclonal Antibody Calretinin recalled
Leica Microsystems is recalling Novocastra Liquid Mouse Monoclonal Antibody Calretinin, Ncl-l-calret-566, distributed in 10 states. The recall was initiated on 22 Mar 2016 and the FDA has classified it as Class II.
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-1704-2016
- FDA event ID
- 73823
- Recalling firm
- Leica Microsystems, Buffalo Grove, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Mar 2016
- FDA classified
- 20 May 2016
- Reported
- 1 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Mar 2016 | Recall initiated by company | |
| 20 May 2016 | Classified by FDA | +59 days |
| 1 Jun 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining.
Product as listed by the FDA
Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
Where it was distributed
Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of Canada.
AlaskaCaliforniaFloridaGeorgiaMinnesotaMontanaNew JerseyOhioTexasWashington
Questions about this recall
Why was it recalled?
Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining.
Which lots are affected?
Lot numbers: 6025204, 6029060, 6029949, 6035923 and 6036060.
Where was it sold?
Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of Canada.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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