CLASS II Device recall · Reported 8 Jun 2016 · FDA Enforcement Report
Novocastr Liquid Mouse Monoclonal Antibody CDX2 recalled
Leica Microsystems is recalling Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment, distributed in 12 states. The recall was initiated on 5 Apr 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-1877-2016
- FDA event ID
- 73802
- Recalling firm
- Leica Microsystems, Buffalo Grove, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Apr 2016
- FDA classified
- 1 Jun 2016
- Reported
- 8 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 5 Apr 2016 | Recall initiated by company | |
| 1 Jun 2016 | Classified by FDA | +57 days |
| 8 Jun 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
Where it was distributed
Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
ArkansasCaliforniaConnecticutFloridaIdahoIllinoisIndianaMontanaOhioPennsylvaniaTennesseeTexas
Questions about this recall
Why was it recalled?
Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling.
Which lots are affected?
1ml size Novocastr Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) with lot numbers 6032734, 6033766, 6037153 and 6039088.
Where was it sold?
Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in 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.
Other products in this recall event
1 other product · FDA event 73802| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Novocastr Liquid Mouse Monoclonal Antibody Renal Cell recalled | Leica Microsystems | Other | 12 states |
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