|
Class 1 Device Recall VITEK 2 |
|
Date Initiated by Firm |
March 14, 2024 |
Date Posted |
April 25, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1464-2024 |
Recall Event ID |
94264 |
510(K)Number |
K161217
|
Product Classification |
System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
|
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 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 |
Code Information |
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
|
Recalling Firm/ Manufacturer |
Biomerieux Inc 595 Anglum Rd Hazelwood MO 63042-2320
|
For Additional Information Contact |
bioMerieux Customer Service Center 800-682-2666
|
Manufacturer 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.
|
FDA Determined Cause 2 |
Employee error |
Action |
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. |
Quantity in Commerce |
49215 units |
Distribution |
Worldwide |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = LON and Original Applicant = bioMerieux, Inc.
|
|
|
|