Radiometer America Inc: pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.

Recall number

Z-1075-2014

Recalling firm

Radiometer America Inc

Product

pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.

Status

Terminated

Initiated

2013-07-05

Posted

2014-02-24

Terminated

2015-09-19

Reason

RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.

Root cause

Under Investigation by firm

Action

On 7/18/2013, the firm sent Product Notification letters to their customers.

Quantity

38,890 units (7,860 units imported into the US)

Distribution

Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, 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, VT, WA, WI, WV & WY, and the countries of Bermuda and Canada.

Lot, serial or model codes

Model #: 942-063 Lot #'s: R338 to R493

510(k) numbers

["K041874","K980130"]

PMA numbers

not on file

Product code

CHL

Firm FEI

1523456

Firm city

Westlake

Firm state

OH

Firm country

not on file

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

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