FDA Medical Device Recalls (openFDA)
Abbott Laboratories Inc.: Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma
- Recall number
- Z-1434-2012
- Recalling firm
- Abbott Laboratories Inc.
- Product
- Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma
- Status
- Terminated
- Initiated
- 2010-03-10
- Posted
- 2012-04-18
- Terminated
- 2012-04-18
- Reason
- Observed particulate matter in some reagent cartridges.
- Root cause
- Material/Component Contamination
- Action
- Abbott Laboratories sent a Product Recall notification letter dated March 10, 2010, to all affected customers. The notification letter contained an explanation, patient impact, neccassary actions, and contact information. Customers were instructed to determine if they currently have any of the affected product in their inventory. Discontinue use and destroy any remaining inventory of the affected product in accordance with their institution's policies and procedures. Completed the enclosed Customer Reply Form. If customers forwarded any of the affected product they should provide a copy of the notification letter to their customers. For any questions customers should call Customer Service at 1-877-422-2688. For questions regarding this recall call 626-440-0705.
- Quantity
- 2718 (U.S. 652)
- Distribution
- US nationwide and internationally to Germany, Hong Kong, Australia, New Zealand, Trinidad/Tobago, and Jamaica. No dsitribution of Canada or Mexica.
- Lot, serial or model codes
- Lot Numbers: 77056HW00; 80051HW00; 83030HW00 Exp dates: 04/15/2011, 07/15/2011, and 10/10/2011, respectively.
- 510(k) numbers
- ["K981758"]
- PMA numbers
- not on file
- Product code
- CIX
- Firm FEI
- 2018433
- Firm city
- South Pasadena
- 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