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Terminated

StreamLab Analytical Workcell. General Purpose Laboratory Device.

FDA Recall Z-0373-05 · Posted 2004-12-28

Recalling FirmDade Behring , Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2004-11-12
Date Terminated2005-03-28
Product Quantity15 units

Reason for Recall

Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems.

Firm 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.

Root Cause

Other

Distribution Pattern

The product was shipped to hospitals in IL, MD, NJ, OH, and VA. The product was also shipped to Italy, Spain, and Portugal.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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