FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Access Immunoassay Systems CORTISOL, Part Number: 33600
- Recall number
- Z-2621-2010
- Recalling firm
- Beckman Coulter Inc.
- Product
- Access Immunoassay Systems CORTISOL, Part Number: 33600
- Status
- Terminated
- Initiated
- 2010-02-17
- Posted
- 2010-09-29
- Terminated
- 2012-04-19
- Reason
- The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot of Access Cortisol reagent (REF 33600) identified above may produce suppressed patient results. Beckman Coulter also confirmed customer reports that the two lots of Access Progesterone reagent (REF 33550) identified above may produce suppressed patient results and an increased incidence of I
- Root cause
- Other
- Action
- Two (2) Product Corrective Action (PCA) letters with attached Customer Response form were sent on the week of February 15, 2010 to the affected customers. The letters provide the customers with an explanation of the problem identified and instruct the customers to discontinue use of Access Progesterone and Access Cortisol Reagents, lot numbers referenced. For product replacements consignees were instructed : (1) In the United States, please contact Customer Service at 1-800-526-3821; (2) In Canada, please contact Customer Service at 1-800-463-7828; (3) Outside of the United States and Canada, contact your local Beckman Coulter Representative. If consignees need assistance or have any questions regarding this notification, they were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter Representative.
- Quantity
- 7282 units
- Distribution
- United States & Canada
- Lot, serial or model codes
- Lot Number: 913550
- 510(k) numbers
- ["K954733"]
- PMA numbers
- not on file
- Product code
- CGR
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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