Positive control serum recalled over negative recovery of the HBsAg analyte
Techno-Path is recalling 76 units of Multichem ID-B positive control serum because of potential negative recovery of the HBsAg analyte on the Alinity i platform.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a quality control that fails to recover its analyte can mask a testing problem, and no injuries are reported.
Plain-English summary
Multichem ID-B, model SR103B, is being recalled. The product is intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for determinations including anti-HIV-1 IgG, anti-HBc IgG and anti-HTLV-I IgG.
The firm identifies the potential of negative recovery of the HBsAg analyte across two lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
This record covers 76 units from lot SB140524P, carrying UDI 05391523442312. The product was distributed in California, Colorado, Connecticut, Florida, Hawaii, Illinois, Louisiana, Michigan, Minnesota, Nevada, New York, Oregon, South Carolina, Tennessee, Texas, Wisconsin and Wyoming. The FDA has classified the action as Class II.
A positive control that reads negative undermines the quality check on hepatitis B surface antigen testing. Laboratories holding the affected lot should follow the firm's instructions.
The recalled product
- 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…
- Manufacturer
- TECHNO-PATH MANUFACTURING LTD.
- Affected units
- 76
Distribution
Part of a larger recall action
This product is one of 2 recalled by TECHNO-PATH MANUFACTURING LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · TECHNO-PATH MANUFACTURING LTD.
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