FDA recall Z-0218-2019

Product

NucliSENS¿ Magnetic Extraction Reagents

Reason for recall

Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.

Distribution

Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.

Key facts

Status

Terminated

Initiation date

2018-09-17

Report date

2018-10-31

Termination date

2020-05-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marcy L'Etoile, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0218-2019