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 424039; q) AST-N423, REF 424042; r) AST-N422, REF 424056; s) AST-N436, REF 424440; t) AST-N809, REF 424703; u) AST-N806, REF 424709; v) AST-N807, REF 424710; w) AST-N808, REF 424711; x) AST-N810, REF 424712; y) AST-N812, REF 424721

Class I - Dangerous

🏥 Medical Devices Recalled: March 14, 2024 Biomerieux Diagnostic Equipment

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Biomerieux Inc
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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 424039; q) AST-N423, REF 424042; r) AST-N422, REF 424056; s) AST-N436, REF 424440; t) AST-N809, REF 424703; u) AST-N806, REF 424709; v) AST-N807, REF 424710; w) AST-N808, REF 424711; x) AST-N810, REF 424712; y) AST-N812, REF 424721

Product Codes/Lot 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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1464-2024

Related Recalls

VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 423864 AST-N406 423869 AST-N407 423870 AST-N409 423925 AST-N412 423936 AST-N413 423928 AST-N414 423933 AST-N415 423934 AST-N416 423935 AST-N417 423880 AST-N419 423948 AST-N421 424055 AST-N428 424320 AST-N429 424321 AST-N430 424322 AST-N433 424389 AST-N439 424501 AST-N440 424502 AST-N443 424541 AST-N444 424587 AST-N467 424857 AST-N476 424934 AST-N478 425052 AST-N480 425084 AST-N481 425085 AST-N485 425182 AST-N496 425265 AST-N800 423310 AST-N802 423706 AST-N804 424634 AST-N808 424711 AST-N810 424712 AST-N811 424713 AST-N813 424722 AST-N815 425054 AST-XN09 423425 AST-XN15 423829 AST-XN17 423673 AST-XN18 423874 AST-XN20 423947 AST-XN21 424197 AST-XN22 424199 AST-XN23 424198 AST-XN24 424351 AST-XN26 424500 AST-XN28 424586 AST-XN29 424604 AST-XN30 424639 AST-XN31 424640 AST-XN32 424678 AST-XN33 424723 AST-XN34 424752 AST-XN35 424810 AST-XN36 424860 AST-XN37 424888 AST-XN38 425074 AST-XN39 425086 AST-XN40 425095 AST-XN41 425204 AST-XN42 425309 Update 4/2/26 -- Additional product references not manufactured at time of initial notification. These products will not be distributed within the United States. AST-N484 Ref. 425181 AST-N486 Ref. 425183 AST-N491 Ref. 425206 AST-N494 Ref. 425224 AST-N485 Ref. 425182 AST-XN41 Ref. 425204 AST-XN42 Ref. 425309 AST-N504 Ref. 425491

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