Recall Z-2163-2012 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer America Inc
The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura
| Date | Aug 8, 2012 (initiated Jul 5, 2012) |
| Status | Terminated |
| Reason | A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t |
| Root cause | Software design |
| Action | The firm, Radiometer, sent two "Priority Level: Urgent" letters one dated July 9, 2012 and the other dated July 24, 2012 to its affected customers via FedEx with tracking. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to complete and return the attached Recall Response Fax Form via fax to 800-736-0601. The letter informed the customers that a local service representative will be contacting them shortly to install a software update that will prevent this from occuring (in the event that you utilize HL7 version 2.5 or intend |
| Quantity | 6854 ABL 7xx units |
| Distribution | Worldwide distribution: USA (nationwide) including the states of AK, AL, AR, AZ, BM, CA, CO, CT, DC, 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, and WY, and the countries of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002290 | ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) Radiometer Medical A/S, Sep 13, 2000 |
| K041874 | ABL800 FLEX Radiometer Medical Aps, Oct 8, 2004 |
| K100777 | ABL837 FLEX ANALYZER Radiometer Medical Aps, Dec 10, 2010 |
| K110416 | ABL835 FLEX ANALYZER WITH PLEURAL PH Radiometer Medical Aps, Mar 24, 2011 |
| K111897 | ABL90 Radiometer Medical Aps, Jul 19, 2011 |
| K992859 | ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE Radiometer America, Inc., Jan 10, 2000 |