Recall Z-2170-2012— Abbott Point Of Care Inc.
Class II · Terminated
Class II FDA medical device recall by Abbott Point Of Care Inc., initiated 2012-02-01, terminated 2013-02-08. It names one FDA 510(k) clearance: K053597. Product: i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.. Reason: The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure..
- Recalling firm
- Abbott Point Of Care Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-02-01
- Terminated
- 2013-02-08
- Firm location
- Princeton, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
Reason for recall
The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.