Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 An

FDA device recall Z-2571-2011 · posted 2011-06-16 · Terminated

Recall details

Recalling firm

Radiometer America Inc

Reason for recall

Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. Retention of fluids between the wrinkles can cause a positive bias resulting in calcium measuring errors. This situation poses a risk to the safety of patients, particularly when the measurement results are used

Action taken

The firm, Radiometer America, sent a "MEDICAL DEVICE FIELD CORRECTION" letter dated April 14, 2011, to all affected customers. The letter describes the product, problem and the actions to be taken. The letter provides the customers with a series of steps to be taken when replacing the Calcium Membrane (Until further notice the above procedure must be carried out when replacing the Calcium membrane). The letter also provides quality control instructions for verifying calcium performance. Additionally, the customer is required to manually adjust the upper and lower QC limits on the analyzer in relation to the limits printed on the insert sheet in order to detect the bias during quality control measurements (This must be done for every lot of QC ampoules used, and for any new lot of ampoules installed). The letter asks that each customer complete and return the attached form via fax to 440-871-0463, in order to verify that the notification letter was received. Questions should be directed to the firm's Technical Support staff at 800-736-0600, Opt. 4.

Root cause

Pending

Status

Terminated

Product code

JFP

Quantity affected

30323 boxes

Distribution

Worldwide Distribution--USA (nationwide) including the states of AK, AL, AR, AZ, BM, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR,

Date initiated

2011-04-07

Date posted

2011-06-16

Date terminated

2012-02-19

Location

Westlake, OH

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