Z-0218-2019 Class II Terminated
FDA device recall Z-0218-2019 was initiated by BioMerieux SA on Sep 17, 2018 and is designated Class II. Reason for recall: Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product. The recall status is terminated (terminated May 18, 2020). Affected quantity: 42 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 31, 2018
- Initiation Date
- Sep 17, 2018
- Termination Date
- May 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42 units
Product Description
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 Pattern
Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.
Code Information
Reference # 200293, Lot # 17121501, Expiration date 11/28/2018
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0218-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026