Cobas u 601 urinalysis test system recall
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…
Why was Cobas u 601 urinalysis test system recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 04015630932252
- Product
- 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…
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 636
- Distribution
- US Nationwide distribution.
- Recall date
- November 24, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)