Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
Reason for recall: Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2. Distribution: Worldwide Quantity: 49215 units Lot/code info: a) AST-N334, REF 418984, UDI/DI 3573026490720, Lot/Serial Numbers: 7742790503, 7742805403, 7742828503, 7742830203; b) AST-GN95, REF 421982, UDI/DI 3573026565923, Lot/Serial Numbers: 6852740103, 6852751503, 6852778503, 6852811503; c) AST-GN99, REF 423102, UDI/DI 3573026608132, Lot/Serial Numbers: 6892721103, 6892727403, 6892740503, 6892740403, 6892743503, 6892761503, 6892770403, 6892790103, 6892799403, 6892799103, 6892810103, 6892818103, 6892831503; d) AST-N390, REF 423340, UDI/DI 3573026612177, Lot/Serial Numbers: 1402832104, 1402761504; e) AST-N391, REF 423341, UDI/DI 3573026612269, Lot/Serial Numbers: 1412831104, 1412754504; f) AST-N392, REF 423342, UDI/DI 3573026612283, Lot/Serial Numbers: 1422819204; g) AST-N395, REF 423491, UDI/DI 3573026615802, Lot/Serial Numbers: 1452725204; h) AST-N401, REF 423643, UDI/DI 3573026616816, Lot/Serial Numbers: 1512776404, 1512789204, 1512811104, 1512831104, 1512720404, 1512729404, 1512729104, 1512748504, 1512754104, 1512785404; i) AST-N402, REF 423644, UDI/DI 3573026616830, Lot/Serial Numbers: 1522720504, 1522733404; j) AST-N404, REF 423664, UDI/DI 3573026617356, Lot/Serial Numbers: 1542819204; k) AST-N802, REF 423706, UDI/DI 3573026617752, Lot/Serial Numbers: 0422750104, 0422763104, 0422764504, 0422782404, 0422820504, 0422820404; l) AST-N405, REF 423864, UDI/DI 3573026621360, Lot/Serial Numbers: 1552757504, 1552792404, 1552800404, 1552820104, 1552733104, 1552741504, 1552757404; m) AST-N417, REF 423880, UDI/DI 3573026621704, Lot/Serial Nu
3573026490720, 3573026565923, 3573026608132, 3573026612177, 3573026612269, 3573026612283, 3573026615802, 3573026616816, 3573026616830, 3573026617356, 3573026617752, 3573026621360, 3573026621704, 3573026622725, 3573026622749, 3573026625283, 3573026625337, 3573026625610, 3573026631666, 3573026635978, 3573026636067, 3573026636081, 3573026636104, 3573026636128, 3573026636296
Official record: FDA (Device enforcement) ↗
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