| Subject: | FDA Announces Class I Medical Device Recall of Ortho-Clinical Diagnostics, Inc. VITROS® Immunodiagnostic Products Troponin I Reagent Pack |
| Category: | Food and Drug Administration (FDA)
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| Published: | Fri, 25 May 2007 - 02:00 pm |
| The FDA has classified the recall of Ortho-Clinical Diagnostics, Inc. VITROS® Immunodiagnostic Products, Troponin I Reagent Packs, Lots 3151 and 3170 (Catalog No. 1949882) as a Class I Recall. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that, should this particular malfunction occur, use of the affected product may cause serious injury or death if the problem is not corrected. This recall was reviewed... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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