FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650
- Recall number
- Z-2195-2010
- Recalling firm
- Beckman Coulter Inc.
- Product
- IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650
- Status
- Terminated
- Initiated
- 2010-05-21
- Posted
- 2010-08-10
- Terminated
- 2012-05-22
- Reason
- Beckman Coulter is initiating a recall of IMMAGE Immunochemistry Systems Buffer 1 (BUF1) due to received reports of increased recovery of control and patient samples using the lots of IMMAGE BUF1. Some lots of BUF1 have been reported to cause high shifts in recovery of control or patient samples. Quality Control failures may result after replacing BUF1 with a different lot.
- Root cause
- Nonconforming Material/Component
- Action
- Beckman Coulter will send a Product Corrective Action (PCA) letter on the week of April 19, 2010 to the affected customers. The letter provided the customers with an explanation of the problem and a work around.
- Quantity
- 1309
- Distribution
- Worldwide: U.S., Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Iceland, Ireland, Italy, Japan, Liechtenstein, Macao, Malaysia, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey and United Kingdom,
- Lot, serial or model codes
- Lot#s: T908069, T908104, T909110, T001036 ( This lot was not shipped to customers.)
- 510(k) numbers
- ["K962294"]
- PMA numbers
- not on file
- Product code
- JQX
- 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