FDA Medical Device Recalls (openFDA)
Sekisui Diagnostics Llc: MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
- Recall number
- Z-1902-2012
- Recalling firm
- Sekisui Diagnostics Llc
- Product
- MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
- Status
- Terminated
- Initiated
- 2012-05-29
- Posted
- 2012-06-27
- Terminated
- 2012-11-14
- Reason
- Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.
- Root cause
- Storage
- Action
- Sekisui Diagnostics Llc sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated May 29, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately stop using the affected product and to destroy any remaining inventory. A Confirmation of Notification Form was attached for customers to complete and return via fax to 902-628-6504. Contact the firm at 902-628-0984 for questions regarding this notice.
- Quantity
- 1600 kits
- Distribution
- Illinois
- Lot, serial or model codes
- Lot 41928UQ11 {exp 2013-01 -31 )
- 510(k) numbers
- ["K042330"]
- PMA numbers
- not on file
- Product code
- LDP
- Firm FEI
- 3008776041
- Firm city
- Framingham
- Firm state
- MA
- 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