Reported May 17, 2017 · Terminated
Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas…
Roche Diagnostics Corporation
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: Roche Diagnostics Corporation · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- Sample probes associated with
cobas 6000 Series Systemcobas 8000 Modular Analyzer Seriescobas c 311 analyzer cobas c 501/502 cobas
- c 701/702 cobas 8000 ISE Product UsageThe cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyzer Series is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit. The cobas c 311 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride
- Lot codes and dates
- sample probe catalog numbers04547241001 - cobas c 501/502 05899427001 - cobas c 311 04945794001 - cobas c 701/702
- and cobas 8000 ISE Lot numbers
170 of 170 codes
cobas c 311 0490232027049023385504902364270490238543049024193704902483220490250880049023571304902520290490256963 cobas c 501c 502 04902337620490233764049023376604902337670490233777049023590404902359050490235906049023590704902359490490235950049023759404902375950490237353049023735404902375970490237598049023760004902376020490237604049023760604902389550490238957049023889304902388950490238896049023889804902388990490242149049024215104902421530490242155049024232704902423280490242329049024233004902423310490250491049025049204902504930490250494049025049504902504960490251032049025103304902510340490251036049025252404902525270490252529
- Amount recalled
- 3946
Where it was sold
- Nationwide
Why it was recalled
Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and lead to a disturbance of the sample liquid level detection (LLD). When disturbance of the sample liquid level detection (LLD) occurs, the affected sample probe may dip into the sample material deeper than intended. This may lead to carryover and medical risk cannot be excluded.
This product could cause temporary or reversible health problems — stop using it.
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