Summary
The FDA issued a Class I for Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST by Remel Inc. Reason: An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results.
Details
Source
Device Recall
External ID
Z-0331-2023
Action Date
2022-12-14
Status
Terminated
Category
device
Product Description
Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
Lot/Code Info: Lot Numbers: B2125, B2115
Quantity Affected: 588 units
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.
Distribution
US Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-20
Company
Lenexa, KS
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Remel Inc has 25 FDA actions in our database, including 25 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Remel Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Remel Inc have FDA actions?
Remel Inc has 25 FDA actions in our database, including 25 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0331-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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