FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.
- Recall number
- Z-1396-2009
- Recalling firm
- Beckman Coulter Inc
- Product
- Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.
- Status
- Terminated
- Initiated
- 2007-09-27
- Posted
- 2009-05-22
- Terminated
- 2009-05-27
- Reason
- Beckman Coulter initiated the field action as a result of recent internal testing following the CLSI EP-5A - Evaluation of Precision Performance of Clinical Chemistry Devices protocol, it was determined that the total imprecision for the Access Myoglobin Reagent is greater than or equal to 10% across the expected physiological range rather than the stated claim less than 8%. Based on internal tes
- Root cause
- Labeling False and Misleading
- Action
- An Urgent: Product Corrective Action (PCA) letter was mailed via US Postal Service on October 08, 2007 to the customers that received Access Myoglobin Reagent kits informing them about the issue. The letter also informed customers that the product insert in the Access Assay Manual will be revised with the new range to reflect the new imprecision claim. Customers were instructed to: (1) Share this information with their laboratory staff and retain the letter for their Quality System documentation, (2) Complete and return the enclosed fax-back response form within 10 days so that Beckman Coulter, Inc. can be assured that the customer received the notification, and (3) Contact Customer Technical Support at 1-800-854-3633 or your local Beckman Coulter, Inc. representative for questions or additional information regarding the notification.
- Quantity
- 20,727
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- All Lot Numbers.
- 510(k) numbers
- ["K021229"]
- PMA numbers
- not on file
- Product code
- DDR
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28