Remel, Inc Recalls Thermo Scientific Gram Negative IVD AST Sensititre Plate for risk of potential false susceptible results
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Name: Thermo Scientific Gram Negative IVD AST Sensititre Plate
- Catalog Number: GN2F, GN3F, GN4F, GN6F, GN7F, HPB1, ESB1F, CMC5VGNF, CMC7AFLF, MDRGN3F, STP6F, STP7F
- Lot Numbers: See Recall Database Entry
- Distribution Dates: January 26, 2021 to October 16, 2022
- Devices Recalled in the U.S.: 18,906
- Date Initiated by Firm: October 20, 2022
The Thermo Scientific Gram Negative IVD AST Sensititre Plate is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram-negative organisms, comprising of Enterobacterales, Pseudomonas aeruginosa, and other non-Enterobacteriaceae. Each plate contains various dilutions of antimicrobial agents at appropriate concentrations. Results can be read manually by visual reading of growth or automatically on an ARIS/OptiRead using fluorescence.
The Thermo Scientific Gram Negative IVD AST Sensititre Plates are used only by trained laboratory personnel to test the susceptibility of Gram-negative bacterial infections to specific antibiotics by monitoring the detection of bacterial growth. Results are used as an aid to select the drug of choice for treatment.
Reason for Recall
Remel, Inc. is recalling the Thermo Scientific Gram Negative IVD AST Sensititre Plates due to the risk of potential false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with the following antibiotics: Carbapenem (doripenem, ertapenem, meropenem, imipenem), cefepime, piperacillin/tazobactam, and aztreonam.
The test results from the affected product may indicate that treatment with these antibiotics will stop or slow the growth of Proteae Tribe bacteria (including Proteus spp., Providencia spp., Morganella Morganii) when that may not be accurate. A false susceptibility result could lead patients to receive an ineffective treatment and experience serious injury or health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and even death.
The firm has received one complaint associated with these products and FDA has received five Medical Device Reports associated with these products. There are no known injuries or deaths.
Who May be Affected
- Patients with Gram negative bacterial infections tested using the Thermo Scientific Gram Negative IVD AST Sensititre Plates.
- Health care and laboratory personnel performing antimicrobial susceptibility testing on patient with bacterial infections using the Thermo Scientific Gram Negative IVD AST Sensititre Plates.
What to Do
On October 25, 2022, Remel sent an Urgent Medical Device Correction notifying customers of the issue. The letter included the following actions:
- Do “NOT REPORT” any result for Protea tribe (including Proteus spp., Providencia spp., Morganella Morganii) due to the risk for false susceptible results when tested with Thermo Scientific Sensititre MIC Susceptibility Plates.
- Pass on the notification to all who need to be aware within the organization.
- Complete and return the Acknowledgement form via email to MBD.email@example.com.
Remel also noted that the “NOT REPORT” recommendation as well as the addition of limitations for testing with the antibiotics known as carbapenems (imipenem, doripenem, meropenem, ertapenem), cefepime, piperacillin/tazobactam and aztreonam will be added to the Instructions for Use for these products.
Customers with questions about this recall should contact Thermo Fisher Scientific Microbiology at 800-255-6730 or email firstname.lastname@example.org.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.