CLASS II Device recall · Reported 18 Aug 2021 · FDA Enforcement Report
Etest Imipenem Relebactam recalled by Biomerieux
Biomerieux is recalling Etest Imipenem Relebactam, distributed nationwide in the US. The recall was initiated on 24 Jun 2021 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-2226-2021
- FDA event ID
- 88242
- Recalling firm
- Biomerieux, Hazelwood, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jun 2021
- FDA classified
- 6 Aug 2021
- Reported
- 18 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Test Kits & Diagnostics
Timeline
| 24 Jun 2021 | Recall initiated by company | |
| 6 Aug 2021 | Classified by FDA | +43 days |
| 18 Aug 2021 | 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
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii. The countries of Austria, Belgium, Croatia, Czech Republic, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland and United Kingdom.
Nationwide ArkansasArizonaCaliforniaColoradoDelawareFloridaGeorgiaHawaiiIllinoisIndianaKansasKentuckyMassachusettsMarylandMaineMichiganMinnesotaMissouriNorth CarolinaNebraska
Questions about this recall
Why was it recalled?
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
Which lots are affected?
Ref 420927 (US Product) Lot numbers 1007888860, 1008598340, 1008701580, 1007607290, 1007888870, 1008390030, 1008598350 and 1008701590 and Ref 420925 (not distributed in US):Lot Codes: 1007888860, 100859840 and 1008701580
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii. The countries of Austria, Belgium, Croatia, Czech Republic, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland and United Kingdom.
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 |
| Device | CLASS II | Myla comprises Ast Filters in conjunction with Vitek MS recalled | Biomerieux | Other | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |