Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system. |
|---|---|
| Recall Number | Z-0408-2013 |
| Classification | Class II |
| Code Info | Lots 12135AE and 12171BB |
| Product Distributed Qty | 959 cartons |
| Reason For Recall | Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations, QC and patient samples. The Abnormal Reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation. |
Event Detail
| Event Id | 62835 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| City | Newark |
| State | DE | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-09 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | USA (nationwide) including the states of AL, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and WI. |
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