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Terminated

Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.

FDA Recall Z-2303-2013 · Posted 2013-09-30

Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeKHP
Date Initiated2012-10-08
Date Terminated2013-12-24
Product Quantity13,632 boxes/4 membranes

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043218ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XXRadiometer Medical Aps · 2005-05-10K002290ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)Radiometer Medical A/S · 2000-09-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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