CLASS I Device recall · Reported 14 Dec 2022 · FDA Enforcement Report
Thermo Scientific Sensititre Plate, GN4F, Gram Negative IVD AST recalled
Remel is recalling Thermo Scientific Sensititre Plate, GN4F, Gram Negative IVD AST, distributed nationwide in the US. The recall was initiated on 20 Oct 2022 and the FDA has classified it as Class I.
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-0327-2023
- FDA event ID
- 91104
- Recalling firm
- Remel, Lenexa, KS
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 20 Oct 2022
- FDA classified
- 7 Dec 2022
- Reported
- 14 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Oct 2022 | Recall initiated by company | |
| 7 Dec 2022 | Classified by FDA | +48 days |
| 14 Dec 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Product as listed by the FDA
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Which lots are affected?
Lot Numbers: B2232B, B2197, B2012, B1355, B1181, B1173, B1125A
Where was it sold?
US Nationwide Distribution
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
Other products in this recall event
8 other products · FDA event 91104This product is part of a recall event; the main page for the event is Thermo Scientific, Sensititre STP6F, Gram Negative IVD AST recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Thermo Scientific, Sensititre STP6F, Gram Negative IVD AST recalled | Remel | Other | Nationwide | |
| CLASS I | Thermo Scientific, Sensititre GN7F, Gram Negative IVD AST recalled | Remel | Other | Nationwide | |
| CLASS I | Thermo Scientific, Sensititre HPB1, Gram Negative IVD AST recalled | Remel | Other | Nationwide | |
| CLASS I | Thermo Scientific, Sensititre GN6F, Gram Negative IVD AST recalled | Remel | Other | Nationwide | |
| CLASS I | Thermo Scientific, Sensititre CMC5VGNF, Gram Negative IVD AST recalled | Remel | Other | Nationwide | |
| CLASS I | Thermo Scientific, Sensititre MDRGN3F, Gram Negative IVD AST recalled | Remel | Other | Nationwide | |
| CLASS I | Thermo Scientific, Sensititre CMC7AFLF, Gram Negative IVD AST recalled | Remel | Other | Nationwide | |
| CLASS I | Thermo Scientific, Sensititre STP7F, Gram Negative IVD AST recalled | Remel | Other | Nationwide |
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