Roche Diagnostics Operations, Inc.: cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use

Is my product affected?

cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use

• UPC 08445605190
• UPC 08445567190
• UPC 08253153190
• UPC 08058580190

Check against the official notice below — it lists the full affected range.

What happened

Roche Diagnostics Operations, Inc. is recalling the cobas pro integrated solutions-cobas c 503 analyzer, a chemistry analyzer used in clinical settings. The recall affects 152 kits and 7 units distributed to Illinois, Florida, Georgia, and West Virginia. The affected products have catalog numbers 08445605190, 08445567190, 08253153190, and 08058580190.

The analyzer poses a safety concern because residual reagent can occasionally transfer from the conus into the reaction cuvette during subsequent pipetting (the 1st or 2nd measurement), causing inaccurately low results for therapeutic drug monitoring tests. The source document does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring).

Details from the source

Reason for recall: During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring). Distribution: Domestic: IL, FL, GA, WV Quantity: 152 kits and 7 units Lot/code info: Catalog Number 08445605190 08445567190 08253153190 08058580190

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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