Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of wh
FDA device recall Z-2303-2013 · posted 2013-09-30 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KHP
- Quantity affected
- 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
- Date initiated
- 2012-10-08
- Date posted
- 2013-09-30
- Date terminated
- 2013-12-24
- Location
- Westlake, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX (K043218) | Radiometer Medical Aps | 2005-05-10 |
| ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) (K002290) | Radiometer Medical A/S | 2000-09-13 |