Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In

FDA device recall Z-1293-2015 · posted 2015-03-18 · Terminated

Recall details

Recalling firm

Radiometer America Inc

Reason for recall

Negative drift on QC during in-use lifetime of CREA membranes can be observed.

Action taken

Radiometer sent a Product Notification letter dated November 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to perform the following steps immediately: " Perform one quality control measurement using S7835 AutoCheck 6+, level 1 on already installed Crea membrane units to verify the Crea performance. If the QC result is out of range, new Crea A and Crea B membranes must be installed. Until further notice the following must be carried out every 24 hours: " Perform one quality control measurement using S7835 AutoCheck 6+, level 1 to verify the Crea performance. If the QC result is out of range, new Crea A and Crea B membranes must be installed. Please do not report Crea results unless the membrane unit has been verified as described above. If you already run S7835 AutoCheck 6+ level 1, every 24 hours, as part of your regular QC schedule, you do not need to do anything additional. Please review your QC results to ensure the results are within the QC range. Please complete and return the attached fax form, with your signature as soon as possible or within 7 days. Customers with questions were instructed to contact Radiometer America Technical Support at 1-800-736-0600, option 4. For questions regarding this recall call 440-871-8900, ext 209.

Root cause

Under Investigation by firm

Status

Terminated

Product code

CGL

Quantity affected

10,824 boxes

Distribution

Worldwide Distribution - USA including NM, NC, TN, OH, NE, CA, MO, GA, MA, TX, WV, PA, NY, VA, MN, IN, ME, MD, IL, MI, KS, WI, FL, WA, CT, OK, CO, and Internationally to Canada, Denmark, Spain, Italy,

Date initiated

2014-10-29

Date posted

2015-03-18

Date terminated

2015-07-02

Location

Westlake, OH

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