Recalls / —

—#194986

Product

NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.

FDA product code

PPM — General Purpose Reagent

Device class

Class 1

Medical specialty

Pathology

Affected lot / code info

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.

Why it was recalled

There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

bioMerieux, Inc.

Address

100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2022-07-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #194986. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.