Z-0880-2021Class II

Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized...

Name: Z-0880-2021 Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized...
Creator: Abbott Point Of Care Inc.
Published: 2020-12-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-12-22 / Terminated

FDA source

Abbott Point Of Care Inc. began a recall of Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in... on 2020-12-22. FDA classified it as Class II and gives the reason as "Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0880-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-22
Posted: 2021-01-19
Terminated: 2023-09-01
Recalling firm: Abbott Medical
Product: Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y.
FDA root cause: Under Investigation by firm
Action: Abbott Point of Care notified Customers via email beginning on 22 December 2020. Customer letters will begin shipping via FedEx on 28-December-2020 for delivery on or around 29-December-2020. Letter states reason for recall, health risk and action to take: While Abbott Point of Care continues to investigate this issue, if reporting ionized calcium is required, it is recommended that the i-STAT CG8+ and EG7+ cartridges be used only: within 3 days of removal from refrigerated storage for lot numbers between *20100 and *20339 within 7 days of removal from refrigerated storage for lot numbers *20340 and above Where *= lot letter A, K, L, M, N, W and Y If your facility is unable to manage to the recommended action outlined above, Abbott Point of Care recommends that your facility disable and not report the ionized calcium test on the i-STAT CG8+ and EG7+ cartridges and use an alternate i-STAT cartridge or method for reporting ionized calcium. Please see additional information below on how to disable the ionized calcium test for these cartridges. Please confirm receipt and understanding of this communication by responding to the business reply form included with this letter. Additional information regarding potential solutions will be provided separately by APOC. If you have forwardedany i-STAT CG8+ and EG7+ cartridges to another facility, we request that you please provide a copy of this letter to them. Your Abbott Point of Care sales and support team will be contacting you to review interim solutions for the challenges this communication may bring. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 1-844-256-9531, or via email at [email protected] or visit the Abbott Point of Care website www.pointofcare.abbott. Additionally, please report any questions or concerns about the performance of the ionized calcium test on the i-STAT CG8+ and EG7+ cartridges to Abbott Point of Care Tec
Quantity in commerce: 2,820,000 cartridges US and 2,273,453 catridges OUS
Distribution: Nationwide
Product codes and lots: Stored at room temperature (18 to 30¿C) for periods of time in excess of: 3 days for lot numbers *20100 to *20339 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y Primary GTIN (01) 00054749000163)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0880-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0880-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-19
Z-0881-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-19

Product code CHL

K940918Class III-Stat 200 Portable Clinical AnalyzerI-Stat Corp. / cleared 1994-05-10

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)