FDA Medical Device Recalls (openFDA)
Abbott Health Products, Inc.: IMx HAVAB Controls In Vitro Test
- Recall number
- Z-0660-05
- Recalling firm
- Abbott Health Products, Inc.
- Product
- IMx HAVAB Controls In Vitro Test
- Status
- Terminated
- Initiated
- 2005-03-04
- Posted
- 2005-03-29
- Terminated
- 2005-09-29
- Reason
- Abbott identified through investigational studies that IMxHAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMxHAVAB Package Insert.
- Root cause
- Other
- Action
- Abbott identified through investigational studies that IMx HAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package insert. If a control value is out of the specified range, the assay run is invalid and assay recalibration may be indicated. If the control values are within range as specified in the package insert, the assay run is valid and the patient results are not impacted.
- Quantity
- 373 Kits
- Distribution
- The recalled IMx HAVAB Controls were distributed nationwide in the United Stated, including Puerto Rico and internationally were distributed to Canada, Peru, Germany, Japan, Australia, and Singapore. There are US Government accounts.
- Lot, serial or model codes
- Lot # 21059Q100 Expiration Date: May 20, 2005
- 510(k) numbers
- not on file
- PMA numbers
- ["P780012S007"]
- Product code
- LOL
- Firm FEI
- 2623532
- Firm city
- Barceloneta
- Firm state
- not on file
- Firm country
- PR
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