FDA Device Recalls

Recalls /

#33137

Product

Power Processor Aliquot Tube Labels Part 800255

Affected lot / code info
Lots 21045673; 2105246; 21361906.

Why it was recalled

Labels are missing an expiration date and storage instructions, increasing the likelihood that they will not be used by the expiration date or may be stored under conditions that would cause adhesive failure and loss of identity of sample or aliquot during testing.

Root cause (FDA determination)

Other

Recalling firm

Firm
Beckman Coulter Inc
Address
200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Timeline

Recall initiated
2003-06-23
Posted by FDA
2004-07-23
Terminated
2004-08-30
Status

Source: openFDA Device Recall endpoint. Recall record ID #33137. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.