Please be aware, this recall is a correction, not a product removal.
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 this issue and suggesting they use a different testing method if the results show that the MIC (minimal inhibitory concentration) is in a range of 0.5, 1, 2.
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 March 15, 2024, bioMérieux sent all affected customers an Urgent Field Safety Notice.
The letter requested customers to:
- Continue using the kits with consideration of alternative method to determine MIC, if this method results in MIC of 0.5, 1, 2.
- Distribute this information to all appropriate personnel, retain a copy of this letter, 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 included and return it to Usfieldactions@biomerieux.com 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.
