Z-0266-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 24, 2021
- Initiation Date
- October 18, 2021
- Termination Date
- May 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 636
Product Description
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.
Reason for Recall
A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of Nitrite results was observed at creatinine levels up to 9,000 mg/L.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI 04015630932252