Recall Z-1076-2019— Abbott Laboratories, Inc

Name: FDA recall Z-1076-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-18

Class II · Terminated

Class II FDA medical device recall by Abbott Laboratories, Inc, initiated 2018-07-18, terminated 2020-08-13. It names one FDA 510(k) clearance: K983070. Product: Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.. Reason: The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low..

Recalling firm: Abbott Laboratories, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-07-18
Terminated: 2020-08-13
Firm location: Irving, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K983070 — CKAbbott Laboratories·cleared 1999-02-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.

Reason for recall

The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.

Data sourced from openFDA. This site is unofficial and independent of the FDA.