Recall Z-0761-2020— Abbott Point Of Care Inc.

Name: FDA recall Z-0761-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-16

Class II · Terminated

Class II FDA medical device recall by Abbott Point Of Care Inc., initiated 2019-10-16, terminated 2020-05-04. It names 2 FDA 510(k) clearances: K051433, K031739. Product: i-STAT cTnI cartridge. Reason: 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..

Recalling firm: Abbott Point Of Care Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-10-16
Terminated: 2020-05-04
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

2 on FDA's record

K051433 — I-STAT CREATINE KINASE MB (CK-MB)I-Stat Corporation·cleared 2005-12-15
K031739 — I-STAT CARDIAC TROPONIN (CTNI) TESTI-Stat Corporation·cleared 2003-09-02

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

i-STAT cTnI cartridge

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.

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