FDA Device recall Z-0501-2026
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the pre…
- FDA Device
- Class II
- ongoing
- Published 2025-11-19
On 2025-11-19 the FDA classified a Class II recall of Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the pre… by Techno Path Manufacturing, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0501-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-17 |
| Published | 2025-11-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Techno Path Manufacturing |
| Distribution | CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY |
Product
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
Reason
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.
Identifiers
| code_info | Model Number: SR103B. UDI: (01)05391523442312(240)SR103B(17)260531(10)SB140524P. Lot number: SB140524P. Expiration Date: 31-5-2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0501-2026%22
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