FDA Devices recall · Reported December 14, 2022
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
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…
Remel Inc recalled Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST - a critical-severity action.
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST was recalled by Remel Inc in December 14, 2022. Reason: An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Pl…. Check the official notice for the remedy. Verify recall #Z-0327-2023 with the FDA Devices before acting.
The recall
Remel Inc issued this critical-severity FDA Devices recall-An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Pl….
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- December 14, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0327-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0327-2023) was formally reported on December 14, 2022, with the manufacturer initiating the action on October 20, 2022. It is classified under Critical severity (Class I), with a current status of Terminated. Remel Inc is listed as the recalling firm, operating out of Lenexa, KS. Federal records list the affected scope as 1917 units.
The documented reason for this recall is: 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., Morgane… Distribution data in the federal record shows the product reached: US Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0327-2023 |
| Date reported | December 14, 2022 |
| Date initiated | October 20, 2022 |
| Recalling firm | Remel Inc |
| Firm location | Lenexa, KS |
| Affected scope | 1917 units |
| Distribution | US Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0327-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
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Methodology · Corrections · Archive as of August 2026