Home › BIOMERIEUX , INC. › VITEK® COMPACT PRO
VITEK® COMPACT PRO
BIOMERIEUX , INC. · Model 423465 · UDI-DI 03573026615499
LON
Prescription
1
510(k) clearances
3,999
Adverse events (6 deaths)
240
Recalls
23
Facilities
Description
VITEK COMPACT PRO is an automated system that performs bacterial ID and AST. minimum, a total of 15 ID and/or AST cards can be processed simultaneously per run. can be extended to 30 or 60.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-13 | Becton Dickinson & Co. | Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. |
| 2026-08-13 | Becton Dickinson & Co. | Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. |
| 2026-07-24 | Biomerieux Inc | The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential r |
| 2026-06-26 | Beckman Coulter Inc. | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." |
| 2026-06-26 | Beckman Coulter Inc. | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." |
| 2026-06-04 | Biomerieux Inc | Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. |
| 2025-09-23 | Becton Dickinson & Co. | Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials ar |
| 2025-06-26 | bioMerieux, Inc. | Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards |
| 2024-10-31 | Becton Dickinson & Co. | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv |
| 2024-08-01 | Becton Dickinson & Co. | Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate tre |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.