Biomerieux Inc VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i) AST-N402, REF 423644; j) AST-N404, REF 423664; k) AST-N802, REF 423706; l) AST-N405, REF 423864; m) AST-N417, REF 423880; n) AST-N408, REF 423924; o) AST-N409, REF 423925; p) AST-N420, REF Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i) AST-N402, REF 423644; j) AST-N404, REF 423664; k) AST-N802, REF 423706; l) AST-N405, REF 423864; m) AST-N417, REF 423880; n) AST-N408, REF 423924; o) AST-N409, REF 423925; p) AST-N420, REF
Brand
Biomerieux Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Biomerieux Inc is recalling VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST- due to Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false suscep. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
BioMerieux issued an URGENT FIELD SAFETY NOTICE to its consignees on 03/14/2024 via email. The notice explained the issue, impact to patient, and provided the consignee (user) with alternate testing methods. BioMerieux issued another URGENT FIELD SAFETY NOTICE dated 07MAY2024 to its consignees on May 9, 2024, via email. This letter includes the statement, "however, no results for the Ceftriaxone (cro02n) should be reported outside the lab."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026