Recall Z-2079-2019 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Abbott Laboratories
ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human B type natriuretic peptide (BNP) in human EDTA plasma.
| Date | May 24, 2019 |
| Status | Terminated |
| Reason | Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing. |
| Root cause | Under Investigation by firm |
| Action | Abbott Laboratories notified customers on about 05/24/2019 via "Product Recall" letter. If customers did not have an alternate calibrator and/or control lots available in inventory and a valid calibration calibration curve has been generated, then customers should immediately order replacement calibrator and/or control lots. Valid calibration curves generated with the affected calibrator lots can still be used as long as controls not listed on the customer notification letter remain within range. The control lots listed in the letter CANNOT be used to validate the calibration curves. Destroy |
| Quantity | 6,623 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed worldwide to ALGERIA, ANDORRA, AUSTRIA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060964 | ARCHITECT BNP ASSAY, MODEL 8K28 Fujirebio Diagnostics,Inc., May 25, 2006 |