| Subject: | The FDA Issues a Class I Recall of Abbot Laboratories ARCHITECT® STAT Troponin-I Immunoassay |
| Category: | Food and Drug Administration (FDA)
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| Published: | Fri, 8 Jun 2007 - 03:00 pm |
| The FDA has issued a Class I recall of Abbott Laboratories ARCHITECT® STAT Troponin-I Immunoassay, List #2K41, all lots. Apparently a small number of clinical laboratories have reported inconsistent or invalid test results at very low levels of troponin-I (i.e., less then 0.1ng/mL). The assay may report falsely elevated or falsely decreased results at and near this low level, which may impact patient treatment. A falsely low troponin result may cause a doctor to send a patient home... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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