Dimension CTNI-In vitro diagnostic test intended to recall
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the…
Why was Dimension CTNI-In vitro diagnostic test intended to recalled?
Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00842768013836GA232320221119 Lot Number: GA2323 Exp. Date: 11-19-2022 Recall Extended 9/21/22: UDI: 00842768013836BA308820230329 Lot Number: BA3088 Exp. Date: 2023-03-29
- Product
- Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 113 units; Extended: 52 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, IL MN, MS, NC, ND, NH, OK, SD, TN, TX, WA and the countries of Argentina, Brazil, Canada, France, Germany, India, Mexico, Poland, Portugal, Slovakia, Spain.
- Recall date
- July 13, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)