Roche Diagnostics cobas Integra Albumin Gen.2 recall
Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the…
Why was Roche Diagnostics cobas Integra Albumin Gen.2 recalled?
Due to low Quality Control recovery and invalid Calibration.
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?
Lot # 33962301. Expanded on 12/20/19 to include lot 37437301
- Product
- Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the…
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 7,032 units (Expanded on 12/20/19 to include 29,696 additional units)
- Distribution
- US Nationwide distribution including the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA and WI. Updated as of 12/20/19 to include the following additional US states: CO.
- Recall date
- October 23, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)