VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Reported: August 16, 2023 Initiated: June 5, 2023 #Z-2357-2023
Product Description
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Reason for Recall
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Details
- Recalling Firm
- ORTHO-CLINICAL DIAGNOSTICS
- Units Affected
- 4,013 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Location
- Bridgend, N/A
Frequently Asked Questions
What product was recalled? ▼
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack. Recalled by ORTHO-CLINICAL DIAGNOSTICS. Units affected: 4,013 units.
Why was this product recalled? ▼
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 16, 2023. Severity: Moderate. Recall number: Z-2357-2023.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11