FDAAugust 20, 2020device
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.
What to do
FDA enforcement status: Terminated
Brands named
roche diagnostics operationsrocheroche diagnostics
UPCs
06368590190
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASiemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay2026-05-07
- FDAdirectCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-22026-04-30
- FDABioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.2026-04-22
- FDAepoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;2026-04-02
- FDABiofire Spotfire Respiratory/Sore Throat Panel REF: 4234852026-04-01
- FDADimension Creatinine Flex reagent cartridge. Material Number: 10872079.2026-03-18
- FDALeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) ...2026-03-13
- FDA(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the fo...2026-03-13
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →