Reported Dec 1, 2021 · Ongoing
ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF…
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 c4000 REF 02P24-01/2P241P861R24and 1R25ARCHITECT c8000 REF 01G06-11/1G06ARCHITECT c16000 REF 03L77-01/3L77
- Lot codes and dates
- Product Description/List Number
- ARCHITECT c4000 Module List Number2P24
- UDI(01)00380740003746(21)c4123456(240)02P2401
- Serial Numbers
4,058 of 4,058 codes
C400000C400010C400011C400012C400013c400014c400015C400016C400017C400018C400019C400020C400023C400024C400025C400026C400027C400030C400031C400032C400034C400035C400036C400038C400039C400040C400041C400042C400043C400045C400046C400047C400049C400050C400051C400053C400054C400055C400056C400057C400058C400060C400061C400062C400063C400064C400065c400066C400067C400068C400069C400070C400071C400072C400073C400074C400075C400077C400078C400079
- Amount recalled
- 7,535 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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