FDA Medical Device Recalls (openFDA)
Radiometer America Inc: Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
- Recall number
- Z-2303-2013
- Recalling firm
- Radiometer America Inc
- Product
- Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
- Status
- Terminated
- Initiated
- 2012-10-08
- Posted
- 2013-09-30
- Terminated
- 2013-12-24
- Reason
- RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the Lactate membrane.
- Root cause
- Process control
- Action
- On 11/07/2012, the firm sent "Urgent Field Safety Notices to their customers. The product issue was described and recommended actions were provided. Customers may contact 1 (800) 736-0600, option 4 if questions.
- Quantity
- 13,632 boxes/4 membranes
- Distribution
- Nationwide Distribution, including the states of: AK, AL, AR, AZ, BM, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV.
- Lot, serial or model codes
- Part Number: 942-066 R1741 to R1869
- 510(k) numbers
- ["K002290","K043218"]
- PMA numbers
- not on file
- Product code
- KHP
- Firm FEI
- 1523456
- Firm city
- Westlake
- Firm state
- OH
- 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