Generic Name: (1), (2), (3) Discrete-mode Automated Clinical Chemistry Analyzers; (4) Immuno-luminescence Analyzer — Trade Name: (1) Vitros Xt7600 — (2) Vitros 5600 — (3) Vitros 5600ii — (4) Vitros 3600
- Recalling firm
- Name of Manufacturer/Distributor: Ortho Clinical Diagnostics, Inc. — Address of Manufacturer/Distributor: Gate City Osaki East Tower, 1-11-2 Osaki, Shinagawa-ku, Tokyo — License Type: Type III...
- Product
- Lot: ビトロス XT7600 対象台数 83台 機器シリアル番号 76000115,76000121,76000131,76000135,76000136 76000217,76000255,76000256,76000306,76000336 76000341,76000544,76000546,76000660,76000696 76000699,76000715,76000740,76000758,76000761 76000819,76000828,76000831,76000841,76000844 76000884,76000885,76000892,76000899,76000900 76000902,76000950,76000988,76000993,76001002 76001012,76001018,76001019,76001020,76001113 76001114,76001115,76001116,76001169,76001175 76001180,76001246,76001252,76001259,76001262 76001344,76001360,76001373,76001391,76001459 76001522,76001523,76001585,76001586,76001601...
- Reason
- This device is equipped with a function that displays the code "RE (reagent expired)" on the result screen, lab report, and quality control report when a test is performed using expired reagents, thereby alerting the operator that the results were obtained using expired reagents. Following an investigation by the manufacturer, it has been confirmed that on the affected devices running software version 3.8.0 or higher, when Vitros Luminescent Reagents A and B (hereinafter “Luminescent Reagents”), which are components of in vitro diagnostic medical devices, are used for measurement, the “RE...
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/a37644ff-b3d7-4e9c-8444-7a1c0f2100b7