Recall Z-1238-2012
Beckman Coulter Inc. · initiated November 10, 2011
Product
Access Ostase Calibrators, Part Number: 37305, Subsequent Product Code: JIS. The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
Codes / lots: Lot Numbers: Expiration dates: 013489 11/30/2010 111530 09/30/2011 013490 01/31/2011 113463 10/31/2011 015210 02/28/2011 114259 10/31/2011 018854 03/31/2011 114260 11/30/2011 020419 05/31/2011 115484 12/31/2011 022834 06/30/2011 116658 01/31/2012 109632 07/31/2011
Reason for recall
The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access Ostase Calibrator and QC lots that contain the implicated raw material.
FDA-determined cause: Process design
Action taken
Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 9, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard all remaining inventory. In addition, a Response Form was enclosed for customers to complete and return. Contact Beckman's Customer Support Center at (800) 854-3633 for questions regarding this notice.
Details
- Recall number
- Z-1238-2012
- Initiated
- November 10, 2011
- Posted by FDA
- March 21, 2012
- Terminated
- June 26, 2012
- Product code
- CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
- Quantity
- 2,228 units total (440 units in US)
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong, Hungary, India,Ireland, Italy, Japan, Jordan, Lebanon, Liechtenstein, Mexico, Morocco, Netherlands, New Zealand, Panama, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia…
- Recalling firm
- Beckman Coulter Inc., Brea, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1239-2012 | Access Ostase QC, Part Number: 37309. The Access Ostase QC is intended for monitoring…The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet… | 11/10/2011Terminated |
| Z-1240-2012 | Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access…The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet… | 11/10/2011Terminated |