FDAOctober 20, 2022device
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
remel
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOxoid Agglutinating Sera, Salmonella 9-0 R309573012026-03-25
- FDAYeastone Broth, 11ML, 10/BOX YY34622026-03-24
- FDACampy CVA Medium 100/PK, R012722026-02-05
- FDA1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT34502025-11-12
- FDABlood Agar,5% Sheep Blood 100/PK, Product Number R012022025-07-11
- FDAStrep Selective II Agar, Product Number R018592025-07-11
- FDABlood/MacConkey Biplate 100/PK, Product Number R020492025-07-11
- FDABlood/EMB, Levine 100/PK, Product Number R020412025-07-11
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