Remel Inc recalls Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
See all recalls from Remel Inc →Recalled Product
Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: B2247, B2096, B1445, B1263, B1176, B0503A
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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