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U.S. Department of Health and Human Services

Class 2 Device Recall Fentanyl Reagent Kit

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 Class 2 Device Recall Fentanyl Reagent Kitsee related information
Date Initiated by FirmJanuary 20, 2020
Create DateApril 17, 2020
Recall Status1 Terminated 3 on January 14, 2021
Recall NumberZ-1743-2020
Recall Event ID 85229
Product Classification Enzyme immunoassay, opiates - Product Code DJG
ProductFentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Code Information Lots: H1801, C1942, D1945, H1901, H1933, L1909  
FEI Number 3000215862
Recalling Firm/
Manufacturer		 Carolina Liquid Chemistries Corp
510 W Central Ave Ste C
Brea CA 92821-3032
For Additional Information ContactAllison Nestor
877-722-8910 Ext. 135
Manufacturer Reason
for Recall		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
FDA Determined
Cause 2		Labeling design
ActionOn 01/20/20 Immediate Action Required notifications were emailed to customers inquiring about the disposition of discontinued products; whether they had been used, if there was remaining inventory. Customers were asked to fill out and return the Immediate Action Required form. Customers were provided with the following contact information: 336-722-8910 and carolinachemistries.com
Quantity in Commerce90 test kits/devices
DistributionU.S.: NC, TX, FL, NY, AZ, NJ, NH, CA
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.
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