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U.S. Department of Health and Human Services

Class 2 Device Recall Microphthalmia Transcription Factor

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 Class 2 Device Recall Microphthalmia Transcription Factorsee related information
Date Initiated by FirmJuly 14, 2017
Create DateSeptember 12, 2017
Recall Status1 Terminated 3 on August 02, 2024
Recall NumberZ-3122-2017
Recall Event ID 78055
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
ProductCell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods.
Code Information Product Code PA0803, Lot No. 46524, Exp. Date 06/25/2019
Recalling Firm/
Manufacturer		 Leica Biosystems Richmond Inc.
5205 Route 12
Richmond IL 60071
For Additional Information Contact
815-678-2000
Manufacturer Reason
for Recall		A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
FDA Determined
Cause 2		Storage
ActionAdvance Cancer Diagnostics sent an Urgent Medical Device Recall letter dated July 12, 2017, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to identify any affected products, discard them, and complete and return the Medical Device Acknowledgement Form by fax to 1-847-236-3000. For questions regarding this recall call 815-678-2000.
Quantity in Commerce10
DistributionNationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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