Z-0210-2009
Separation Technology ClearCRIT Capillary Tubes 75mm/0.5mm ID. Catalog number 270-107. Separation Technology...
Drummond Scientific Co / initiated 2008-08-01 / Terminated / root cause: manufacturing process
Drummond Scientific Co began a recall of Separation Technology ClearCRIT Capillary Tubes 75mm/0.5mm ID. Catalog number 270-107. Separation Technology Inc, 1096 Rainer Drive, Altamonte Springs, FL... on . The reason FDA records is "presence of OSCS contaminant". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0210-2009
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Drummond Scientific Co
- Product
- Separation Technology ClearCRIT Capillary Tubes 75mm/0.5mm ID. Catalog number 270-107. Separation Technology Inc, 1096 Rainer Drive, Altamonte Springs, FL 32714. Heparin-treated capillary tube used for spun hematocrit packed cell volume (PCV) determination.
- Product code
- GIO Tube, Collection, Capillary Blood
- Reason for recall
- presence of OSCS contaminant
- Root cause tag
- manufacturing process
- FDA root cause
- Material/Component Contamination
- Action
- The recalling firm issued recall letters dated 8/1/08 via certified mail to the label owners informing them of the problem and the need to notified their customers.
- Quantity in commerce
- 1000 vials
- Distribution
- Nationwide Distribution --- including states of FL and MA.
- Product codes and lots
- Lot number 1058
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