Data Foundry

Medical device recalls 2012

i-Stat BNP cartridges Abbott Point of Care Inc — Class II medical device recall Z-2170-2012

Terminated recall by Abbott Point Of Care Inc., reported 2012-08-15, distributed in AZ, CO, GA. The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric press

Recall numberZ-2170-2012
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAbbott Point Of Care Inc., Princeton, NJ, United States
Recall initiated2012-02-01
Classified2012-08-09
Reported by FDA2012-08-15
Terminated2013-02-08
DistributedAZ, CO, GA
Countries outside the USAE, AR, AT, AU, BE, BO, BR, CH, CL, CN, CO, CR, DE, DO, ES, FI, FR, GB, GR, HK, HN, IE, IN, IT, KR, KW, MX, NG, NO, OM, PE, PL, PT, PY, QA, RU, SA, SE, SG, SV, TH, TW, ZA

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 for recall

The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2170-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.