FDA Medical Device Recalls (openFDA)
Mega Diagnostics: Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vials
- Recall number
- Z-0743-2007
- Recalling firm
- Mega Diagnostics
- Product
- Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vials
- Status
- Terminated
- Initiated
- 2006-09-20
- Posted
- 2007-04-14
- Terminated
- 2012-06-04
- Reason
- Potential for microorganism growth in the alcohol standard and or unexpected QC changes in the Ammonia portion of the Ammonia/Alcohol control product.
- Root cause
- Other
- Action
- The firm sent a recall notification to their customer in Indonesia and advised them to dispose of the product
- Quantity
- 12 Units
- Distribution
- Country of Indonesia
- Lot, serial or model codes
- Lot# 522202
- 510(k) numbers
- ["K972333"]
- PMA numbers
- not on file
- Product code
- JIX
- Firm FEI
- 3008094524
- Firm city
- Los Angeles
- 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