Recall Z-0272-2022 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories
ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;
| Date | Sep 29, 2021 |
| Status | Open, Classified |
| Reason | Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinolog |
| Root cause | Software design |
| Action | On 09/29/2021, the Firm issued an "Urgent Medical Device Correction" Notification Letter via FedEx priority overnight express informing customers that the Firm has identified 3 potential performance issues with Software version 9.41 and earlier. The 3 issues are: 1. When an Error Code 3382, Unable to process test, internal wash pressure (x) error (y) pipettor occurs, the systems are incorrectly placed into a Scheduled Pause status rather than a Stopped status. As a result, the processing module continues to process tests after the hardware error is detected. This may cause incorrect results t |
| Quantity | 7,535 systems |
| Distribution | U.S.: AK, AL, AR, AZ, 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, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: AFGHANISTAN ALBANIA, ALGERIA, ANDORRA, ANGOLA, ARGENTINA, ARMENIA, AUSTR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983212 | ABBOTT ARCHITECT TESTOSTERONE Abbott Laboratories, Nov 18, 1998 |