FDA Medical Device Recalls (openFDA)
Microgenics Corporation: MAS Omni Immune PRO Controls
- Recall number
- Z-1930-2014
- Recalling firm
- Microgenics Corporation
- Product
- MAS Omni Immune PRO Controls
- Status
- Terminated
- Initiated
- 2013-12-02
- Posted
- 2014-06-26
- Terminated
- 2014-07-08
- Reason
- The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change.
- Root cause
- Labeling Change Control
- Action
- Urgent Medical Device Correction letters were sent on December 2, 2013 to all affected customers and distributors via trackable mail.
- Quantity
- 1393
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.
- Lot, serial or model codes
- Part Number Lot number OPR0-101 OPR015101 OPR0-202 OPR015102 OPR0-303 OPR015103 OPRO-SP OPR01510S All lots have an expiration date of 10/31/2015.
- 510(k) numbers
- ["K110616"]
- PMA numbers
- not on file
- Product code
- JJY
- Firm FEI
- 3010939897
- Firm city
- Fremont
- 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