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U.S. Department of Health and Human Services

Class 2 Device Recall iSTAT CHEM8

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  Class 2 Device Recall iSTAT CHEM8 see related information
Date Initiated by Firm January 15, 2020
Date Posted February 18, 2020
Recall Status1 Terminated 3 on March 02, 2021
Recall Number Z-1262-2020
Recall Event ID 84728
Product Classification Electrode, ion specific, sodium - Product Code JGS
Product i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for the quantitative measurement of sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine, and hematocrit in venous, arterial or capillary whole blood.
Code Information All lots are affected
Recalling Firm/
Manufacturer		 Abbott Point Of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact Stephanie Radek
609-454-9000
Manufacturer Reason
for Recall		 The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and non-waived. Different CLIA standards apply to waived and non-waived tests as well as the facilities that perform these types of tests. The i-STAT CHEM8+ cartridge contains nine measured assays (sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine and hematocrit) and is categorized as a CLIA waived test for venous whole blood samples, meaning this cartridge could be used in a facility with a CLIA Certificate of Waiver as a waived test.
FDA Determined
Cause 2		 No Marketing Application
Action On 1/15/2020, the firm notified customers of the product recall via letters, customer emails, follow-up phone calls/visits by sales representatives, and a website posting at www.pointofcare.abbott. Customers were instructed to do the following: Facilities using the i-STAT BLUE CHEM8+ cartridges in CLIA waived settings should transition to alternate CLIA waived testing methods or engage a reference laboratory for the tests your facility requires. Facilities should discontinue use of the i-STAT BLUE CHEM8+ and CG4+ cartridges with capillary samples. Facilities should use an alternate method, if available, for the tests included in the i-STAT BLUE CHEM8+ and CG4+ cartridges for arterial and venous specimens. If an alternate method is not available, the BLUE CHEM8+ and CG4+ cartridges will still be available while Abbott is working toward FDA clearance for facilities in non-waived settings (i.e., facilities that hold a Certificate of Compliance or Accreditation). Abbott will notify customers if/when the products receive FDA clearance for use with arterial and venous whole blood samples in non-waived settings. However: " Facilities that continue to use the BLUE CHEM8+ and CG4+ cartridges for arterial and venous specimens should inform clinicians and laboratory staff that the performance of these cartridges has not yet been fully characterized. " Clinicians should be advised to consider a patients signs, symptoms, history, and results of other diagnostic tests when interpreting results from these cartridges. If the results do not match the patients clinical presentation, the patient sample should be retested using an alternate test method or a reference laboratory. In order to mitigate risk associated with the performance of these products not yet being fully characterized, Abbott will be actively monitoring the performance of these cartridges. Please report any questions or concerns you have about their performance to Abbott Point of Care Technical Support
Quantity in Commerce 9,049,725
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC 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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