TECHNO-PATH MANUFACTURING LTD.: Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedu

Hazard

Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.

Details from the source

Reason for recall: Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform. Distribution: US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY. Quantity: 51 units Lot/code info: Model Number: SR103B. UDI: (01)05391523442312(240)SR103B(17)261031(10) SB161024P. Lot Number: SB161024P. Expiration Date: 31-10-2026.

UPC codes

05391523442312

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.