Recall Z-0272-2022
Abbott Laboratories · initiated September 29, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;
Codes / lots: Product Description/List Number ARCHITECT c4000 Module List Number: 2P24 UDI: (01)00380740003746(21)c4123456(240)02P2401 Serial Numbers: C400000 C400010 C400011 C400012 C400013 c400014 c400015 C400016 C400017 C400018 C400019 C400020 C400023 C400024 C400025 C400026 C400027 C400030 C400031 C400032 C400034 C400035 C400036 C400038 C400039 C400040 C400041 C400042 C400043 C400045 C400046 C400047 C400049 C400050 C400051 C400053 C400054 C400055 C400056 C400057 C400058 C400060 C400061 C400062 C400063 C400064 C400065 c400066 C400067 C400068 C400069 C400070 C400071 C400072 C400073 C400074 C400075 C400077 C400078 C400079 C400080 C400081 C400083 C400084 C400085 C400086 C400087 C400089 C400090 C400091 C400092 C400093 C400095 C400096 C400098 C400099 C400100 C400101 C400102 C400104 C400105 C400106 C400107 C400108 C400109 C400112 C400114 C400115 C400116 C400117 C400118 C400119 C400120 C400121 C400122 C400123 C400124 C400125 C400127 C400129 C400132 C400133 C400134 C400135 C400136 C400137 c400139 C400140 C400141 C400142 C400143 C400144 C400145 C400146 C400147 C400148 C400149 C400150 C400151 C400152 C400153 C400154 C400155 C400156 C400157 C400158 C400159 C400160 C400161 C400162 C400163 C400164…
Reason for recall
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, endocrinologic, inflammatory analytes.
FDA-determined cause: Software design
Action taken
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 to be generated. 2. When configuring a Calibrator Sample Volume on the Configure Assays screen, if the user selects multiple assays, the calibrator sample volume from one assay may be carried into the calibrator sample volume for another assay. Incorrect calibrator sample volumes have the potential to generate incorrect calibration curves which may lead to incorrect results and delay of results due to the need to reconfigure assay parameters. 3. When performing a backup on the system while the iARM is replenishing the wash buffer at the same time, the iARM looses communication with the System Control Center. The loss of communication may cause the wash buffer container to overflow. This has the potential to lead to physical and chemical hazards. Customers are instructed to follow the Necessary Actions listed in Appendix A until software version 9.45 or software version 9.50 are installed. Appendix A states: For Issue (listed above): #1-The Necessary Actions to be taken by the customers until mandatory upgrade is completed - Stop the processing module and discard any results produced after an Error Code 3382. Perform Corrective Actions for Error Code 3382. For details, refer to System Operations Manual, Section 10: Troubleshooting and diagnostics. #2-The Necessary Actions to be taken by the customers until mandatory upgrade is completed - Verify the correct calibrator sample v
Details
- Recall number
- Z-0272-2022
- Initiated
- September 29, 2021
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- 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, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHAMAS, BAHRAIN, BANGLADESH, BARBADOS, BELARUS, BELGIUM, BELIZE, BENIN…
- Recalling firm
- Abbott Laboratories, Irving, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0271-2022 Class II | ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74…Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues… | 09/29/2021Open, Classified |