Enforcement Report - Week of October 24, 2012
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Product Detail
| Product Description | AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving processes. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including the detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving. |
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| Recall Number | Z-0056-2013 |
| Classification | Class II |
| Code Info | All Serial Numbers |
| Product Distributed Qty | 468 units total (51 units in US) |
| Reason For Recall | The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labeled with two different barcode labels on the AutoMate 2500 Family (previously referred to as OLA2500 Systems) units which can cause misidentification of a sample when software versions lower than version 4.1 is used. |
Event Detail
| Event Id | 63155 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Beckman Coulter Inc. |
| City | Brea |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-04-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) and the following countries: Argentina Australia Austria Belarus Belgium China Croatia Czech Republic Denmark Finland France Germany Hungary India Ireland Israel Italy Japan Korea, Republic of Kuwait Macao Malaysia Netherlands New Zealand Norway Panama Russian Federation Slovakia Slovenia South Africa Spain Sweden Switzerland Turkey United Kingdom |
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