Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215. The Access Hybritech free PSA assay is a paramagnetic
FDA device recall Z-2220-2009 · posted 2009-09-16 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Beckman Coulter incorrectly shipped Access Hybritech free PSA calibrators containing dual calibration cards (Hybritech and WHO) to your lab. The WHO calibration for free PSA is marketed without a PMA.
- Action taken
- Beckman Coulter contacted customers by phone beginning January 11, 2009 and sending a Product Corrective Action letter informing them to discontinue use and discard the referenced product immediately. For further information, contact Customer Technical Support at 1-800-854-3633 or contact your local Beckman Coulter Representative.
- Root cause
- Other
- Status
- Terminated
- Product code
- MTG
- Quantity affected
- 22 Kits
- Distribution
- Nationwide Distribution -- OH, CA, TX, OR, MD, MO, FL and PA.
- Date initiated
- 2008-01-08
- Date posted
- 2009-09-16
- Date terminated
- 2011-11-29
- Location
- Brea, CA
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