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U.S. Department of Health and Human Services

Class 2 Device Recall NUCLISENS

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  Class 2 Device Recall NUCLISENS see related information
Date Initiated by Firm July 20, 2022
Create Date August 23, 2022
Recall Status1 Open3, Classified
Recall Number Z-1564-2022
Recall Event ID 90596
Product Classification General purpose reagent - Product Code PPM
Product NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Code Information Lot numbers distributed in the U.S.: Z012MK1MS, exp. 28-NOV-2022; Z012ML1MS, exp. 28-NOV-2022; Z012NB1MS, exp. 28-DEC-2022; Z013AL1MS, exp. 28-JAN-2023. UDI: 03573026139339.
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact Clinical Customer Support
800-682-2666
Manufacturer Reason
for Recall		 There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recalling firm issued undated letters with a reference number of FSCA#5690 via overnight mail on 7/20/2022. The letter explained the issue and instructed the customers to distribute the information to all appropriate personnel in their laboratory and forward the information to all parties that may use the product, including others to whom the customer may have transferred the product. They are informed they can continue to use the impacted lots of the NUCLISENS Magnetic Silica Ref 280133 listed in Table 1 except for bacterial nucleic acid detection applications, especially Legionella spp, and other applications such as 16S rDNA, 23S rDNA. The recalling firm confirms that all applications for which the negative controls are valid can be safely performed. If the customer is encountering invalid negative controls, they are to stop using it and discard the impacted lot and contact the bioMerieux representative to order lots not concerned by the issue. Based on benefit/risk analysis and to avoid product backorder, the customer is informed that for a short period of time, they may receive some of the lots listed in Table 1 of the letter with an insert that will contain the same information and actions required as previously mentioned. An Acknowledgement Form was enclosed for return to confirm receipt of the notice. The letter listed all lot numbers globally distributed, but the customers in the U.S. only received lot numbers Z012MK1MS, Z012ML1MS, Z012NB1MS, and Z013AL1MS. The U.S. customers could receive other lots listed in the letter at a later time.
Quantity in Commerce 1,301 kits
Distribution Distribution was made to AR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, TN, TX, and VA. There was no government/military distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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