Terminated

Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 Analyzers. The membranes are packaged in a plastic box which contains four (4) membranes per box. Calcium membrane jackets that are used in the ABL505/555, EML105, ABL600, ABL700 Series and ABL800 Analyzers for InVitro testing of samples of whole blood for the parameters pH, PO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, CCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions: FO2Hb, FCOHb, FMetHb, FHHb andFHbF).

FDA Recall Z-2571-2011 · Posted 2011-06-16

Recalling FirmRadiometer America Inc

Recall StatusTerminated

Product CodeJFP

Date Initiated2011-04-07

Date Terminated2012-02-19

Product Quantity30323 boxes

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

Firm Action

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

Distribution Pattern

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, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV, and the countries of: Algir, argentina, Austria, Austrailia, Bahrain, Belarus, Belgium, Brazil, Brunei Darussalam, China, Columbia, Cuba, Greece, Denmark, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greenland, Guatemala, Hungary, India, Iraq, Ireland, Isreal, Italy, Jamaica, Japan, Kasakhstan, Kenya, Lebanon, Lithuania Korea, Malaysia, Malta, mexico, Moldavia, Nepal, New Zealand, Norway, Netherlands, Peru, Philipines, Poland, Portugal, Qatar, Oman, Rumania, Russia, Saudi Arabia, Singapore, Serbia and Kosvo, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Syria, Thailand, The Netherlands, Tunesia, Turkey, UK, Ukraine, United Arabia Emirates, Urguary, Usbekistan, and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043218ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XXRadiometer Medical Aps · 2005-05-10 K980130ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEMRadiometer America, Inc. · 1998-02-09 K974818ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEMRadiometer America, Inc. · 1998-01-16 K962334EML105 ELECTROLYTE METABOLITE ANALYZERRadiometer America, Inc. · 1996-10-24 K954612ABL SYSTEM 625, 615, 605Radiometer America, Inc. · 1995-11-09 K914166ABL505 BLOOD GAS & ELECTROLYTE SYSTEMRadiometer America, Inc. · 1992-01-28

Official Source

View FDA Recall →

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