Cobas u 601 urinalysis test system, Catalog number 06334601001
The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack. The cobas u 601 urine analyzer when used with the cobas u pack is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color and erythrocytes, as well as clarity.
Units Affected: 636
Recall Date: Oct 18, 2021
Mfg:
Roche Diagnostics Operations, Inc.
Mfg Country:
United States
Recall ID: 88879
Product ID: 189933
Enforcement Date: Nov 24, 2021
Last Published: Nov 18, 2021
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Emert Number: Z-0266-2022
Emert Status: Notified