Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1154-04

Power Processor Aliquot Tube Labels Part 800255

Siemens Healthcare Diagnostics Inc. / initiated 2003-06-23 / Terminated / root cause: labeling and UDI

Beckman Coulter Inc began a recall of Power Processor Aliquot Tube Labels Part 800255 on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1154-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Healthcare Diagnostics Inc.
Product
Power Processor Aliquot Tube Labels Part 800255
Reason for recall
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 tag
labeling and UDI
FDA root cause
Other
Quantity in commerce
170 rolls
Product codes and lots
Lots 21045673; 2105246; 21361906.