Reported Dec 1, 2021 · Ongoing
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17…
Abbott Laboratories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Laboratories · 1915 Hurd Dr · Irving, TX · 75038
Is this the product you have?
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87ARCHITECT i2000SR REF 03M74-02/3M74ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
- Lot codes and dates
- Product
- Description/List Number/Serial NumbersARCHITECT
- i1000SR UDI(01)00380740001537(21)I1SR12345(240)01L8601
- List Number1L86
- Serial Numbers
3,246 of 3,246 codes
i1SR00101i1SR00102i1SR00103i1SR00104i1SR00105i1SR00106i1SR00107i1SR00108i1SR00109i1SR00110i1SR00111i1SR00112i1SR00113i1SR00114i1SR00115i1SR00116i1SR00117i1SR00118i1SR00119i1SR00120i1sr00121i1SR00122i1SR00124i1SR00201i1SR00202i1SR00203i1SR00204i1SR00205i1SR00206i1SR00207i1SR00208i1SR00209i1SR00210i1SR00211i1SR00212i1SR00213i1SR00214i1SR00215i1SR00216i1SR00217i1SR00218i1SR00219i1SR00220i1SR00221i1SR00222i1SR00223i1SR00224i1SR00225i1SR00226i1SR00227i1SR00228i1SR00229i1SR00230i1SR00231i1SR00232i1SR00233i1SR00234i1SR00235i1SR00236i1SR00237
- Amount recalled
- 20,994 systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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