Z-2303-2013Class II

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

Name: Z-2303-2013 Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of...
Creator: Radiometer America Inc
Published: 2012-10-08
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2012-10-08 / Terminated / root cause: manufacturing process

FDA source

Radiometer America Inc began a recall of Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood on 2012-10-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2303-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-08
Posted: 2013-09-30
Terminated: 2013-12-24
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.
Product code: KHP Acid, Lactic, Enzymatic Method
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Part Number: 942-066 R1741 to R1869

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2303-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2303-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30

Product code KHP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)