Class 2 Device Recall ARCHITECT cSystems

• Date Initiated by Firm: September 29, 2021
• Create Date: November 19, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0272-2022
• Recall Event ID: 88880
• 510(K)Number: K983212
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77
• Code Information: 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 C400165 C400166 C400167 C400168 C400169 C400170 C400171 C400172 C400173 C400174 C400175 C400176 C400177 C400178 C400179 C400182 C400183 C400184 C400185 C400186 C400187 C400188 C400189 C400190 C400191 C400192 C400195 C400196 C400197 C400199 C400200 C400201 C400202 C400203 C400204 C400205 C400206 C400207 C400209 C400210 C400211 C400212 C400213 C400214 C400215 C400217 C400218 C400220 C400222 C400223 C400224 C400227 c400228 C400229 C400230 C400231 C400232 C400234 C400235 C400236 C400237 C400238 C400239 C400240 C400241 C400242 C400243 C400244 C400245 C400246 C400247 C400248 C400250 C400251 C400252 C400253 C400254 C400256 C400258 C400259 C400260 C400261 C400262 C400263 C400264 C400266 C400268 C400269 C400270 C400271 C400273 C400274 C400275 C400276 C400277 C400278 c400279 C400280 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List Number: 3L77 UDI: (01)00380740005924(21)C16123456(240)03L7701 Serial Numbers: C1600014 C1600015 C1600016 C1600017 C1600024 C1600025 c1600026 C1600027 C1600028 C1600029 C1600030 C1600031 C1600032 C1600033 C1600034 C1600035 C1600036 C1600037 C1600038 C1600040 C1600041 C1600042 C1600043 C1600044 C1600045 C1600046 C1600047 C1600048 C1600049 C1600050 C1600051 C1600052 C1600053 C1600054 C1600055 C1600056 C1600057 C1600058 C1600059 C1600060 C1600061 C1600062 C1600063 C1600064 C1600065 C1600066 C1600067 C1600068 C1600069 C1600070 C1600071 C1600072 C1600073 C1600074 C1600075 C1600076 C1600077 C1600078 C1600079 C1600080 C1600081 C1600082 C1600083 C1600084 C1600085 C1600086 C1600087 C1600088 C1600089 C1600090 C1600092 C1600093 C1600094 C1600095 C1600096 C1600097 C1600098 C1600099 C1600100 C1600101 C1600102 C1600103 C1600104 C1600105 C1600106 C1600107 C1600108 C1600109 C1600110 C1600111 C1600112 C1600113 C1600114 C1600115 C1600116 C1600117 C1600118 C1600119 C1600120 C1600121 C1600122 C1600123 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• Recalling Firm/ Manufacturer: Abbott Laboratories; 1915 Hurd Dr; Irving TX 75038
• For Additional Information Contact: Dana Dominguez Schmidt; 224-667-8598
• Manufacturer 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: 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
• Quantity in Commerce: 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, BERMUDA, BOLIVIA, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, BURKINA FASO, BURUNDI, CAMBODIA, CAMEROON, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DEMOCRATIC REP. OF CONGO, DENMARK, FAROE ISLANDS, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ERITREA, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GEORGIA, GERMANY, GHANA, GREECE, GREENLAND, GUATEMALA, GUINEA, HAITI, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, IVORY COAST, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MADAGASCAR, MALAWI, MALAYSIA, MALDIVES, MALI, MALTA, MAURITANIA, MAURITIUS, MEXICO, MOLDOVA, MONTENEGRO, MONTSERRAT, MOROCCO, MOZAMBIQUE, MYANMAR, NAMIBIA, NEPAL, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, RWANDA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, ST. LUCIA, ST. VINCENT, SURINAME, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TAJIKISTAN, TANZANIA, THAILAND, TRINIDAD & TOBAGO, TUNISIA, TURK & CAICOS, TURKEY, UAE, UGANDA, UK, UKRAINE, URUGUAY, UZBEKISTAN, VIETNAM, WEST BANK/GAZA STRIP, YEMEN, ZAMBIA, ZIMBABWE,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JJE and Original Applicant = ABBOTT LABORATORIES