FDA Device recall Z-0272-2022
ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25
- FDA Device
- Class II
- ongoing
- Published 2021-12-01
On 2021-12-01 the FDA classified a Class II recall of ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25 by Abbott Laboratories, citing twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0272-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-29 |
| Published | 2021-12-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Laboratories |
| Distribution | 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
Product
ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;
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, endocrinologic, inflammatory analytes.
Identifiers
| code_info | Product Description/List Number ARCHITECT c4000 Module List Number: 2P24 UDI: (01)00380740003746(21)c4123456(240)02P240…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0272-2022%22
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