Z-0761-2020Class II

i-STAT cTnI cartridge

Name: Z-0761-2020 i-STAT cTnI cartridge
Creator: Abbott Point Of Care Inc.
Published: 2019-10-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-10-16 / Terminated / root cause: design

FDA source

Abbott Point Of Care Inc. began a recall of i-STAT cTnI cartridge on 2019-10-16. FDA classified it as Class II and gives the reason as "i-STAT cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0761-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-16
Posted: 2019-12-31
Terminated: 2020-05-04
Recalling firm: Abbott Medical
Product: i-STAT cTnI cartridge
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: i-STAT cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.
Root cause tag: design
FDA root cause: Device Design
Action: On October 16, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail. It explains Abbott Point of Care has made the decision to transition U.S. customers using the i-STAT cTnI blue cartridge, list number 06P23-25, to the i-STAT cTnI white cartridge, list number 03P90-25, beginning in November 2019. The i-STAT cTnI blue cartridge, list number 06P23-25, will be discontinued for sale in the United States as of January 1, 2020. It further explains to customers while the i-STAT cTnI blue cartridges can continue to be used for patient testing, APOC recommends that all users of the i-STAT System be informed of the possibility of a higher than expected number of quality check codes while using the i-STAT cTnI blue cartridge and maintain a validated alternate backup method until the i-STAT cTnI white cartridges are received. Your Abbott Point of Care representative will contact you to discuss the details and timing of this transition for your facility. If your facility repeatedly observes the i-STAT cTnI blue cartridges from a single lot generating a higher than expected number of QCCs, please contact APOC Technical Services for support and to report the information. If you have forwarded any i-STAT cTnI blue cartridges to another facility, please provide a copy of this letter to them. ADDITIONAL INFORMATION If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 1-866-324-8114, or via email at [email protected] or contact your Abbott Point of Care support services representative. We appreciate your understanding in this matter and thank you for your continued support of Abbott and Abbott products.
Quantity in commerce: 3,465,875
Distribution: US: AK AL AZ CA CT DC FL GA HI IL IN KS KY MD MI MS NC NE NH NM NV NY OH OK OR PA SC SD TN TX VA WA WV WY
Product codes and lots: List Number: 06P23-25 UDI: (01)00054749001986

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0761-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0761-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-08	2019-12-31

Product code MMI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)