CLASS II Device recall · Reported 29 Aug 2018 · FDA Enforcement Report
bioM¿rieux Vitek 2 NH ID Test Kit recalled by Biomerieux
Biomerieux is recalling bioM¿rieux Vitek 2 NH ID Test Kit, distributed nationwide in the US. The recall was initiated on 23 Jan 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2874-2018
- FDA event ID
- 80491
- Recalling firm
- Biomerieux, Hazelwood, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jan 2018
- FDA classified
- 17 Aug 2018
- Reported
- 29 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 23 Jan 2018 | Recall initiated by company | |
| 17 Aug 2018 | Classified by FDA | +206 days |
| 29 Aug 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Missing desiccant.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
Where it was distributed
US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT. VA. VT. WA. WI, and WV
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoDistrict of ColumbiaFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
Missing desiccant.
Which lots are affected?
Batch/Lot: 245057043 Exp. Date 19JUN2019
Where was it sold?
US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT. VA. VT. WA. WI, and WV
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Biomerieux
All 476| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Vitek 2 Ast-N447 Test Kit Product reference recalled by Biomerieux | Biomerieux | Other | MO |
| Device | CLASS II | Vitek-negative Susceptibility Cards Containing o Polymyxin recalled | Biomerieux | Sterility | Nationwide |
| Device | CLASS II | Vitek¿-negative AST Test Kits (Cards) recalled by bioMerieux | bioMerieux | Sterility | NC |
| Device | CLASS I | Vitek 2 - AST Test kits (in vitro diagnostic test cards recalled | Biomerieux | Other | MO |
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