Recall Z-2571-2011 ยท JFP Electrode, Ion Specific, Calcium
Radiometer America Inc
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
| Date | Jun 16, 2011 (initiated Apr 7, 2011) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Pending |
| 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 analyze |
| Quantity | 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, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV, and the countries of: Algir, argentina, Austria, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043218 | ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX Radiometer Medical Aps, May 10, 2005 |
| K914166 | ABL505 BLOOD GAS & ELECTROLYTE SYSTEM Radiometer America, Inc., Jan 28, 1992 |
| K954612 | ABL SYSTEM 625, 615, 605 Radiometer America, Inc., Nov 9, 1995 |
| K962334 | EML105 ELECTROLYTE METABOLITE ANALYZER Radiometer America, Inc., Oct 24, 1996 |
| K974818 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM Radiometer America, Inc., Jan 16, 1998 |
| K980130 | ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM Radiometer America, Inc., Feb 9, 1998 |