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Terminated

Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749000163(17)181028(10)L18059

FDA Recall Z-0615-2019 · Posted None

Recalling FirmAbbott Point Of Care Inc.
Recall StatusTerminated
Product CodeCHL
Date Initiated2018-09-13
Date Terminated2019-04-04
Product Quantity17550 cartridges

Reason for Recall

Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be generated. When testing with samples with a high concentration of potassium, decreased potassium results may be generated

Firm Action

Abbott Point of Care issued recall letter on 9/13/18 via FedEx , advising of the problem, recommend action to return all unused cartridges to APOC . If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 844-256-9531 or your Abbott Point of Care representative.

Root Cause

Manufacturing material removal

Distribution Pattern

WI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K940918I-STAT 200 PORTABLE CLINICAL ANALYZERI-Stat Corp. · 1994-05-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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