bioMérieux
BIM EPA
Medicare add-on payments
- New
- 0
- Continued
- 1
- Lost
- 0
| Status | Technology | Max add-on payment | Implied cost per case |
|---|---|---|---|
| Continued | VITEK REVEAL AST System | $81 | $125 |
FDA device recalls, last 36 months
FDA data as of . Source: openFDA. FDA data may be out of date.
| Class | Product | Reason | Initiated | FDA record |
|---|---|---|---|---|
| Class I | VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c)… | 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. | Mar 14, 2024 | FDA record |
| Class II | VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811 | 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 risk of false resistant results. False resistant results may… | Jul 24, 2026 | FDA record |
| Class II | FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed,… | Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test. | Jul 16, 2026 | FDA record |
| Class II | BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic | Due to increase in false negative results | Jun 24, 2026 | FDA record |
| Class II | VITEK 2 AST-N447 TEST KIT Product reference 424620 | Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. | Jun 4, 2026 | FDA record |
| Class II | BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. | Contamination to in-vitro diagnostic test may result in false positives. | Apr 22, 2026 | FDA record |
| Class II | Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 | Respiratory/sore throat panel test may result in false negative results and control failures. | Apr 1, 2026 | FDA record |
| Class II | VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o… | Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may… | Jan 5, 2026 | FDA record |
| Class II | BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) | Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures. | Oct 22, 2025 | FDA record |
| Class II | FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the… | FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup. | Jul 10, 2025 | FDA record |
| Class II | VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments,… | Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards | Jun 26, 2025 | FDA record |
| Class II | BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems | Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results. | Apr 30, 2025 | FDA record |
| Class II | FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 | Increased risk of control failures and false negative test results with multiplexed nucleic acid test. | Feb 27, 2025 | FDA record |
| Class II | FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W+1 more products | Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which… | Aug 7, 2024 | FDA record |
| Class II | BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles:… | If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens… | Jun 19, 2024 | FDA record |
| Class II | BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143+1 more products | Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer. | Jun 10, 2024 | FDA record |
| Class II | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit… | Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. | May 16, 2024 | FDA record |
| Class II | BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus… | Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums | Jan 26, 2024 | FDA record |
| Class II | FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic… | Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel. | Jan 26, 2024 | FDA record |
| Class II | FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)+1 more products | Their is a potential for false positive results when using Pneumonia panel. | Dec 14, 2023 | FDA record |
| Class II | The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE…+1 more products | A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may… | Nov 27, 2023 | FDA record |
| Class II | FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The… | Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the… | Oct 17, 2023 | FDA record |
| Class II | BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2… | Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some… | Oct 17, 2023 | FDA record |