Reported Dec 14, 2022 · Terminated
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
Remel Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Remel Inc · 12076 Santa Fe Trail Dr · Lenexa, KS · 66215-3519
Is this the product you have?
- Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
- Lot codes and dates
- Lot Numbers
B2232BB2197B2012B1355B1181B1173B1125A
- Lot Numbers
- Amount recalled
- 1917 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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