FDA Device recall Z-0271-2022
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87
- FDA Device
- Class II
- ongoing
- Published 2021-12-01
On 2021-12-01 the FDA classified a Class II recall of ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87 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-0271-2022 |
| 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 i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
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/Serial Numbers: ARCHITECT i1000SR UDI: (01)00380740001537(21)I1SR12345(240)01L8601 List…Product Description/List Number/Serial Numbers: ARCHITECT i1000SR UDI: (01)00380740001537(21)I1SR12345(240)01L8601 List Number: 1L86 Serial Numbers: i1SR00101 i1SR00102 i1SR00103 i1SR00104 i1SR00105 i1SR00106 i1SR00107 i1SR00108 i1SR00109 i1SR00110 i1SR00111 i1SR00112 i1SR00113 i1SR00114 i1SR00115 i1SR00116 i1SR00117 i1SR00118 i1SR00119 i1SR00120 i1sr00121 i1SR00122 i1SR00124 i1SR00201 i1SR00202 i1SR00203 i1SR00204 i1SR00205 i1SR00206 i1SR00207 i1SR00208 i1SR00209 i1SR00210 i1SR00211 i1SR00212 i1SR00213 i1SR00214 i1SR00215 i1SR00216 i1SR00217 i1SR00218 i1SR00219 i1SR00220 i1SR00221 i1SR00222 i1SR00223 i1SR00224 i1SR00225 i1SR00226 i1SR00227 i1SR00228 i1SR00229 i1SR00230 i1SR00231 i1SR00232 i1SR00233 i1SR00234 i1SR00235 i1SR00236 i1SR00237 i1SR00238 i1SR00239 i1SR00240 i1SR00241 i1SR00242 i1SR01001 i1SR01002 i1SR01003 i1SR01004 i1SR01005 i1SR01006 i1SR01007 i1SR01008 i1SR01009 i1SR01010 i1SR01011 i1SR01012 i1SR01013 i1SR01014 i1SR01015 i1SR01016 i1SR01017 i1SR01018 i1SR01019 i1SR01020 i |
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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-0271-2022%22
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