NUCLISENS easyMAG Magnetic Silica Reagent Kit Contamination Recall
bioMerieux recalls NUCLISENS easyMAG Magnetic Silica reagent kits due to contamination that may cause test failures or delayed results. Affected kits were distributed across 23 U.S. states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device reagent kit used in diagnostic testing. While the contamination presents a risk to diagnostic accuracy and could result in test failures or delays, no illnesses, injuries, or hospitalizations have been reported. The hazard is theoretical rather than actualized.
Plain-English summary
bioMerieux, Inc. is recalling 1,301 kits of NUCLISENS easyMAG Magnetic Silica (REF 280133, 24 x 1.2mL bottles/kit). This product is used for nucleic acid extraction in laboratory and clinical settings. The recall is due to contamination of the extraction reagents, which may result in no result or delayed results when processing samples.
The affected kits were distributed to laboratories in 23 U.S. states: 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. The affected lot numbers are Z012MK1MS (expiration 28-NOV-2022), Z012ML1MS (expiration 28-NOV-2022), Z012NB1MS (expiration 28-DEC-2022), and Z013AL1MS (expiration 28-JAN-2023).
The recalled product
- Product
- NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
- Manufacturer
- bioMerieux, Inc.
- Affected units
- 1,301
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot numbers distributed in the U.S.: Z012MK1MS
- exp. 28-NOV-2022
- Z012ML1MS
- Z012NB1MS
- exp. 28-DEC-2022
- Z013AL1MS
- exp. 28-JAN-2023. UDI: 03573026139339.
Distribution
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