Z-1785-2019 Class II Terminated
FDA device recall Z-1785-2019 was initiated by Randox Laboratories Ltd. on March 11, 2019 and is designated Class II. Reason for recall: Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI. The recall status is terminated (terminated May 15, 2020). Affected quantity: 11420 kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 26, 2019
- Initiation Date
- March 11, 2019
- Termination Date
- May 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11420 kits
Product Description
Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
Reason for Recall
Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI.
Distribution Pattern
Product distributed to CA, DE, WV, and Puerto Rico.
Code Information
lots 4243CK, 4244CK, 4245CK.