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Remel Inc Recall 89416

Description: Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

Remel Inc Recall 89416 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0722-2022
Event ID89416
Event DescriptionThermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Product TypeDevices
DistributionDistribution throughout the United States.
Quantity1210 devices
Recall ReasonThere are lower than expected MICs for some gram negative species.
Device Classification20220316
Device Code InfoProduct Number MDRGN2F; Lots: 1) B1402A (Expiration 2022/Oct05) 2) B1315A (Expiration 2022/Aug06) 3) B1211 (Expiration 2022/May24) 4) B1161A (Expiration 2022/Apr19 5) B0361 (Expiration 2021/Aug31) 6) B0164B (Expiration 2021/Apr16)
Center Classification Date20220304
Recall Initiation Date20220110
Recalling FirmRemel Inc
Initial Notification Letter
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