BioMérieux Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Names: VITEK 2 AST kit
- Product Codes: LON
- Model Numbers: See table below
- Distribution Dates: December 12, 2023 to March 4, 2024
- Devices Recalled in the U.S.: 49,276 kits (985,520 tests)
- Date Initiated by Firm: March 14, 2024
Device Use
The VITEK 2 AST kit, which includes the Gram-negative Susceptibility Card, is a test used to figure out how susceptible certain types of bacteria are to antibiotics. Each card has different antibiotics in it, dried with a special material for growing bacteria. The VITEK 2 machine watches how the bacteria grow in each well on the card for a set amount of time. Then, it gives results showing the minimal inhibitory concentration (MIC) for most combinations of bacteria and drugs, along with whether the bacteria are susceptible (S), intermediate (I), or resistant (R) to the antibiotics.
Reason for Recall
BioMérieux is recalling their VITEK 2 AST cards, an Antimicrobial Sensitivity Testing kit, due to a higher concentration of Ceftriaxone antibiotic in 2 wells. This kit is used for testing how sensitive bacteria are to antibiotics. Some of the cards have more of the antibiotic Ceftriaxone in two of their wells than they should. BioMérieux is telling customers about the potential risk of false susceptible and false resistant results and suggesting they use an alternate testing method for all Ceftriaxone results.
The use of the affected kit may cause serious adverse health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and death.
There have been no reports of injuries or deaths associated with this issue.
Who May be Affected
- Healthcare professionals who use the bioMérieux VITEK 2 AST cards to test the susceptibility of bacteria to antimicrobial agents.
What to Do
On May 9, 2024, bioMérieux sent all affected customers an Urgent Field Safety Notice.
The letter requested customers to:
- Continue the use of the product referenced in this notice; however, no results for the Ceftriaxone (cro02n) should be reported outside the lab.
- Distribute this information to all appropriate personnel, retain a copy of this letter in your files, and forward this information to all parties that may use this product, including others to whom may have received this product.
- Store this notice letter with the bioMérieux VITEK 2 documentation.
- Complete the Acknowledgement Form in Attachment A and return it to your local bioMérieux representative (to be adapted at local level) to confirm receipt of this notice.
Contact Information
Customers in the U.S. with questions about this recall should contact bioMérieux Clinical Customer Service at 1-800-682-2666. For non-urgent inquiries, please contact the Technical Support Center by email at CustomerService-IDAST@biomerieux.com.
The anticipated turnaround time for email inquiries is 24 – 48 hours during normal business hours.
Full List of Affected Devices
| Product | Card Ref | Lot/SN# | Expiry | UDI |
|---|---|---|---|---|
| AST-GN95 | 421982 | 6852740103 | 28-May-25 | 3573026565923 |
| AST-GN95 | 421982 | 6852751503 | 08-Jun-25 | 3573026565923 |
| AST-GN95 | 421982 | 6852778503 | 05-Jul-25 | 3573026565923 |
| AST-GN95 | 421982 | 6852811503 | 07-Aug-25 | 3573026565923 |
| AST-GN99 | 423102 | 6892721103 | 09-May-25 | 3573026608132 |
| AST-GN99 | 423102 | 6892727403 | 15-May-25 | 3573026608132 |
| AST-GN99 | 423102 | 6892740403 | 28-May-25 | 3573026608132 |
| AST-GN99 | 423102 | 6892740503 | 28-May-25 | 3573026608132 |
| AST-GN99 | 423102 | 6892743503 | 31-May-25 | 3573026608132 |
| AST-GN99 | 423102 | 6892761503 | 18-Jun-25 | 3573026608132 |
| AST-GN99 | 423102 | 6892770403 | 27-Jun-25 | 3573026608132 |
| AST-GN99 | 423102 | 6892790103 | 17-Jul-25 | 3573026608132 |
| AST-GN99 | 423102 | 6892799103 | 26-Jul-25 | 3573026608132 |
| AST-GN99 | 423102 | 6892799403 | 26-Jul-25 | 3573026608132 |
| AST-GN99 | 423102 | 6892810103 | 06-Aug-25 | 3573026608132 |
| AST-GN99 | 423102 | 6892818103 | 14-Aug-25 | 3573026608132 |
| AST-GN99 | 423102 | 6892831503 | 27-Aug-25 | 3573026608132 |
| AST-N334 | 418984 | 7742790503 | 17-Jul-25 | 3573026490720 |
| AST-N334 | 418984 | 7742805403 | 01-Aug-25 | 3573026490720 |
| AST-N334 | 418984 | 7742828503 | 24-Aug-25 | 3573026490720 |
| AST-N334 | 418984 | 7742830203 | 26-Aug-25 | 3573026490720 |
| AST-N390 | 423340 | 1402761504 | 18-Jun-25 | 3573026612177 |
| AST-N390 | 423340 | 1402832104 | 28-Aug-25 | 3573026612177 |
| AST-N391 | 423341 | 1412754504 | 11-Jun-25 | 3573026612269 |
| AST-N391 | 423341 | 1412831104 | 27-Aug-25 | 3573026612269 |
| AST-N392 | 423342 | 1422819204 | 15-Aug-25 | 3573026612283 |
| AST-N395 | 423491 | 1452725204 | 13-May-25 | 3573026615802 |
| AST-N401 | 423643 | 1512720404 | 08-May-25 | 3573026616816 |
| AST-N401 | 423643 | 1512729104 | 17-May-25 | 3573026616816 |
| AST-N401 | 423643 | 1512729404 | 17-May-25 | 3573026616816 |
| AST-N401 | 423643 | 1512748504 | 05-Jun-25 | 3573026616816 |
| AST-N401 | 423643 | 1512754104 | 11-Jun-25 | 3573026616816 |
| AST-N401 | 423643 | 1512776404 | 03-Jul-25 | 3573026616816 |
| AST-N401 | 423643 | 1512785404 | 12-Jul-25 | 3573026616816 |
| AST-N401 | 423643 | 1512811104 | 07-Aug-25 | 3573026616816 |
| AST-N401 | 423643 | 1512831104 | 27-Aug-25 | 3573026616816 |
| AST-N401 | 423643 | 1512789204 | 16-Jul-25 | 3573026616816 |
| AST-N402 | 423644 | 1522720504 | 08-May-25 | 3573026616830 |
| AST-N402 | 423644 | 1522733404 | 21-May-25 | 3573026616830 |
| AST-N404 | 423664 | 1542819204 | 15-Aug-25 | 3573026617356 |
| AST-N405 | 423864 | 1552733104 | 21-May-25 | 3573026621360 |
| AST-N405 | 423864 | 1552741504 | 29-May-25 | 3573026621360 |
| AST-N405 | 423864 | 1552757404 | 14-Jun-25 | 3573026621360 |
| AST-N405 | 423864 | 1552757504 | 14-Jun-25 | 3573026621360 |
| AST-N405 | 423864 | 1552792404 | 19-Jul-25 | 3573026621360 |
| AST-N405 | 423864 | 1552800404 | 27-Jul-25 | 3573026621360 |
| AST-N405 | 423864 | 1552820104 | 16-Aug-25 | 3573026621360 |
| AST-N408 | 423924 | 1582734404 | 22-May-25 | 3573026622725 |
| AST-N408 | 423924 | 1582742504 | 30-May-25 | 3573026622725 |
| AST-N408 | 423924 | 1582764404 | 21-Jun-25 | 3573026622725 |
| AST-N408 | 423924 | 1582782504 | 09-Jul-25 | 3573026622725 |
| AST-N408 | 423924 | 1582810504 | 06-Aug-25 | 3573026622725 |
| AST-N408 | 423924 | 1582820104 | 16-Aug-25 | 3573026622725 |
| AST-N409 | 423925 | 1592746404 | 03-Jun-25 | 3573026622749 |
| AST-N409 | 423925 | 1592811104 | 07-Aug-25 | 3573026622749 |
| AST-N417 | 423880 | 192763504 | 20-Jun-25 | 3573026621704 |
| AST-N417 | 423880 | 192819404 | 15-Aug-25 | 3573026621704 |
| AST-N420 | 424039 | 462810404 | 06-Aug-25 | 3573026625283 |
| AST-N422 | 424056 | 482819504 | 15-Aug-25 | 3573026625610 |
| AST-N423 | 424042 | 502750404 | 07-Jun-25 | 3573026625337 |
| AST-N423 | 424042 | 502825504 | 21-Aug-25 | 3573026625337 |
| AST-N436 | 424440 | 672734104 | 22-May-25 | 3573026631666 |
| AST-N436 | 424440 | 672754104 | 11-Jun-25 | 3573026631666 |
| AST-N802 | 423706 | 422750104 | 07-Jun-25 | 3573026617752 |
| AST-N802 | 423706 | 422763104 | 20-Jun-25 | 3573026617752 |
| AST-N802 | 423706 | 422764504 | 21-Jun-25 | 3573026617752 |
| AST-N802 | 423706 | 422782404 | 09-Jul-25 | 3573026617752 |
| AST-N802 | 423706 | 422820404 | 16-Aug-25 | 3573026617752 |
| AST-N802 | 423706 | 422820504 | 16-Aug-25 | 3573026617752 |
| AST-N806 | 424709 | 932729404 | 17-May-25 | 3573026636067 |
| AST-N807 | 424710 | 942723404 | 11-May-25 | 3573026636081 |
| AST-N808 | 424711 | 952758104 | 15-Jun-25 | 3573026636104 |
| AST-N809 | 424703 | 962799404 | 26-Jul-25 | 3573026635978 |
| AST-N810 | 424712 | 972729504 | 17-May-25 | 3573026636128 |
| AST-N812 | 424721 | 992776504 | 03-Jul-25 | 3573026636296 |
| AST-N812 | 424721 | 992777104 | 04-Jul-25 | 3573026636296 |
| AST-N812 | 424721 | 992821404 | 17-Aug-25 | 3573026636296 |
Additional Resources:
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.