FDA Medical Device Recalls (openFDA)
Microgenics Corporation: ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. Catalog Numbers & Description: CAI-XLL, Level L; CAI-XL1, Level 1; CAI-XL2, Level 2; CAI-XL3, Level 3; CAI-XL4, Multi-Pack; CAI-XLS, Sample Pack;
- Recall number
- Z-0637-2012
- Recalling firm
- Microgenics Corporation
- Product
- ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. Catalog Numbers & Description: CAI-XLL, Level L; CAI-XL1, Level 1; CAI-XL2, Level 2; CAI-XL3, Level 3; CAI-XL4, Multi-Pack; CAI-XLS, Sample Pack;
- Status
- Terminated
- Initiated
- 2011-12-14
- Posted
- 2012-01-11
- Terminated
- 2012-10-26
- Reason
- Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges.
- Root cause
- Nonconforming Material/Component
- Action
- On 12/14/2011, ThermoFisher Scientific issued letters via express mail to all its direct consignees, informing them of the affected products and providing instructions on the recall.
- Quantity
- 25,113 Kits
- Distribution
- Nationwide and Worldwide, including Germany, France, Italy and Spain.
- Lot, serial or model codes
- Catalog number, Lot Numbers & Expiration Dates: CAI-XLL, CXL1301L, 31 JAN 2013; CAI-XL1, CXL13011, 31 JAN 2013; CAI-XL2, CXL13012, 31 JAN 2013; CAI-XL3, CXL13013, 31 JAN 2013; CAI-XL4, CXL13014, 31 JAN 2013; CAI-XLS, CXL1301S, 31 JAN 2013
- 510(k) numbers
- ["K061196"]
- 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