Z-1564-2022Class II

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

Name: Z-1564-2022 NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit
Creator: bioMerieux, Inc.
Published: 2022-07-20
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2022-07-20 / Open, Classified / root cause: manufacturing process

FDA source

bioMerieux, Inc. began a recall of NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit on 2022-07-20. FDA classified it as Class II and gives the reason as "There is a potential of no result leading to possible delayed result due to contamination of extraction reagents". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1564-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-20
Posted: 2022-08-23
Recalling firm: bioMerieux, Inc.
Product: NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Product code: PPM General Purpose Reagent
Reason for recall: There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1564-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1564-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-23

Product code PPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)