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Recall Observatory FDA recall evidence

Device product

Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent

Z-1743-2020

January 20, 2020

Class II

Product summary

Firm
Carolina Liquid Chemistries Corp
Event
Event 85229
Status
Terminated
Classification
Class II
Quantity
90 test kits/devices
Official record key
device-enforcement:Z-1743-2020

Official wording

Reason: Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified customers that products are labeled for "Forensic Use Only" and are not FDA Cleared and not to be used for clinical purposes

Code information: Lots: H1801, C1942, D1945, H1901, H1933, L1909

Distribution pattern: U.S.: NC, TX, FL, NY, AZ, NJ, NH, CA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified customers that products are labeled for "Forensic Use Only" and are not FDA Cleared and not to be used for clinical purposes