VITEK 2 - AST Test kits recall
VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c)…
Why was VITEK 2 - AST Test kits recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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 Numbers: 0192763504, 0192819404; n) AST-N408, REF 423924, UDI/DI 3573026622725, Lot/Serial Numbers: 1582810504, 1582820104, 1582734404, 1582742504, 1582764404, 1582782504; o) AST-N409, REF 423925, UDI/DI 3573026622749, Lot/Serial Numbers: 1592811104, 1592746404; p) AST-N420, REF 424039, UDI/DI 3573026625283, Lot/Serial Numbers: 0462810404; q) AST-N423, REF 424042, UDI/DI 3573026625337, Lot/Serial Numbers: 0502750404, 0502825504; r) AST-N422, REF 424056, UDI/DI 3573026625610, Lot/Serial Numbers: 0482819504; s) AST-N436, REF 424440, UDI/DI 3573026631666, Lot/Serial Numbers: 0672734104, 0672754104; t) AST-N809, REF 424703, UDI/DI 3573026635978, Lot/Serial Numbers: 0962799404; u) AST-N806, REF 424709, UDI/DI 3573026636067, Lot/Serial Numbers: 0932729404; v) AST-N807, REF 424710, UDI/DI 3573026636081, Lot/Serial Numbers: 0942723404; w) AST-N808, REF 424711, UDI/DI 3573026636104, Lot/Serial Numbers: 0952758104; x) AST-N810, REF 424712, UDI/DI 3573026636128, Lot/Serial Numbers: 0972729504; y) AST-N812, REF 424721, UDI/DI 3573026636296, Lot/Serial Numbers: 0992777104, 0992776504, 0992821404
- Product
- VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c)…
- Recalling firm
- Biomerieux Inc
- Quantity
- 49215 units
- Distribution
- Worldwide
- Recall date
- May 1, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)