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Class 2 Device Recall StreamLab Analytical Workcell |
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Date Initiated by Firm |
November 12, 2004 |
Date Posted |
December 28, 2004 |
Recall Status1 |
Terminated 3 on March 28, 2005 |
Recall Number |
Z-0373-05 |
Recall Event ID |
30518 |
Product Classification |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
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Product |
StreamLab Analytical Workcell. General Purpose Laboratory Device. |
Code Information |
Software version 3.5 |
Recalling Firm/ Manufacturer |
Dade Behring , Inc. Rte 896, Glasgow Business Community Newark DE 19702
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For Additional Information Contact |
Stanley P. Gorak 302-631-7456
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Manufacturer Reason for Recall |
Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems.
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FDA Determined Cause 2 |
Other |
Action |
The recalling firm issued letters dated 11/12/04 to their customers informing them of the problem. The letter also states that a sales representative will contact them to make arrangements for an upgrade. |
Quantity in Commerce |
15 units |
Distribution |
The product was shipped to hospitals in IL, MD, NJ, OH, and VA. The product was also shipped to Italy, Spain, and Portugal. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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