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Terminated

StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502

FDA Recall Z-0198-2007 · Posted 2006-11-21

Recalling FirmIris Sample Processing
Recall StatusTerminated
Product CodeJQC
Date Initiated2006-09-29
Date Terminated2006-12-13
Product Quantity94 units (Revised on 11/15/06 to 116 units)

Reason for Recall

Rotor may crack and separate causing device to fail. A failed rotor not successfully contained may seriously injure the laboratory worker.

Firm Action

Iris telephoned customers on 9/29/06 and advised them of the recall of the rotor. New rotors were mailed Overnight Confirmed Delivery with instructions for replacement and return of the the old rotor.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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