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U.S. Department of Health and Human Services

Class 2 Device Recall NUCLISENS Lysis Buffer

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  Class 2 Device Recall NUCLISENS Lysis Buffer see related information
Date Initiated by Firm January 10, 2020
Date Posted February 11, 2020
Recall Status1 Terminated 3 on April 14, 2022
Recall Number Z-1365-2020
Recall Event ID 84766
Product Classification General purpose reagent - Product Code PPM
Product NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS
Manufacturer
bioMerieux SA
376, Chemin de l'Orme
69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid from biological specimens.
Code Information Lot 19040201, Expiry 28-Feb-2021
Recalling Firm/
Manufacturer		 BIOMERIEUX - Grenoble
Biomerieux
Institut Christophe Merieux; 5 Rue Des Berges; Cs 30076
Grenoble Cedex 1 France
For Additional Information Contact
800-682-2666
Manufacturer Reason
for Recall		 Following a customer complaint about colored eluates, leading to invalid results bioMerieux has confirmed an issue with NUCLISENS Lysis Buffer, ref. 200292, lot 19040201. The issue is linked to drift of pH electrode dysfunction.
FDA Determined
Cause 2		 Equipment maintenance
Action Consignees notified via FedEx Express 2 day delivery service with recall letter dated 10 January 2020. The letter identified affected product, stated reason for recall, and requested product to not be used for testing of whole blood samples containing blood and other specimens containing blood. Samples with no hemoglobin are not impacted by the issue and can be used with expected performance. A Recall Acknowledgement Form was requested to be completed and returned via fax.
Quantity in Commerce 1024
Distribution No US distribution. No Mexican consignees. International distribution to South Africa, Uruguay, Tanzania, Romania, Netherlands, Macao, Italy, India, Hong Kong, United Kingdom, France, Spain, Germany, China, Chile, Canada, Belgium, Australia, Argentina, Curacao.
Total Product Life Cycle TPLC 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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