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U.S. Department of Health and Human Services

Class 1 Device Recall Thermo Scientific Sensititre CMC7AFLF

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 Class 1 Device Recall Thermo Scientific Sensititre CMC7AFLFsee related information
Date Initiated by FirmOctober 20, 2022
Date PostedDecember 08, 2022
Recall Status1 Terminated 3 on September 30, 2024
Recall NumberZ-0332-2023
Recall Event ID 91104
510(K)NumberK060621 K073424 K860753 K880641 K936305 K983244 
Product Classification Gram negative identification panel - Product Code JWY
ProductThermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
Code Information Lot Numbers: B2281, B2151A, B2034, B1453
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactTom Campbell
913-895-4077
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionThe firm issued an "Urgent Medical Device Correction" notice to its consignees on 10/25/2022 by US mail. The notice explained the issue, risk to health, and notified the consignees of an update to the IFU, specifically, "to add limitations for Carbapenems (Imipenem, Doripenem, Meropenem, Ertapenem), Cefepime, Piperacillin/Tazobactam and Aztreonam added for users to "NOT REPORT" any result for each member of the Protea tribe (including Proteus spp., Providencia spp., Morganella Morganii) to address false susceptible results." Please complete and return the Required Customer Reply form via email to MBD.vigilance@thermofisher.com. Please keep this notification on file. The notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. This correction notification is being made and performed by the US agent, Remel Inc., on behalf of the Foreign Manufacturer of the affected product, Trek Diagnostic Systems Ltd., located in East Grinstead, UK. Trek Diagnostic Systems and Remel Inc., both part of Thermo Fisher Scientific, are investigating the root cause and will implement corrective actions to prevent future recurrence. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com.
Quantity in Commerce1647 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JWY
510(K)s with Product Code = JWY
510(K)s with Product Code = JWY
510(K)s with Product Code = JWY
510(K)s with Product Code = JWY
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