Thermo SCIENTIFIC recall
Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
Why was Thermo SCIENTIFIC 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: B2265A
- Product
- Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
- Recalling firm
- Remel Inc
- Quantity
- 9 units
- Distribution
- US Nationwide Distribution
- Recall date
- December 14, 2022
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)