Reagent, Borrelia Serological Reagent
FDA adverse event reports and recall history for reagent, borrelia serological reagent (product code LSR), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 135
- Deaths
- 0
- Injuries
- 58
- Malfunctions
- 71
Reports per year
Source: FDA adverse event reports by year received, 1998–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-12-01Open, ClassifiedNo Marketing Application
Lyme Test
Distribution without premarket approval/clearance.
- 2013-03-08TerminatedNonconforming Material/Component
ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.
Multiple incidents of low-reacting assay plates.
- 2004-07-20TerminatedOther
VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase Receptable) pouches, 1 x 1.5 ml LYT C1 (human) (positive control bottle), 1 x 1.5 ml LYT C2 (human) (negative control bottle), and 1 x 1.5 ml LYT S1 (human) (standard bottle). The responsible firm on the kit label is bioMerieux sa, 69280 Marcy l''Etoile France. The responsible firm on the insert is bioMerieux, Inc., Durham, NC.
Kit may contain incorrect components
- Open, ClassifiedNonconforming Material/Component
VIDAS Lyme IgM II (LYM), REF 416436
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
- Open, ClassifiedNonconforming Material/Component
VIDAS Lyme IgG II (LYM), REF 417401
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
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