Cobas b 123 POC system cobas b 123 POC system is fully recall
Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes…
Why was Cobas b 123 POC system cobas b 123 POC system is fully recalled?
It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the thickness in the cuvette layer. Internal investigations found the altered thickness of the cuvette was due to production equipment settings. Cuvettes were produced within specifications, but within the upper
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?
Part number: 05169992001 cobas b 123 Fluid Pack COOX, 200 with Lot# 21426121 and Lot# 21426171.
- Product
- Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes…
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 23 units of Fluid Pack COOX, 200 were distributed
- Distribution
- Nationwide Distribution including NE and AZ.
- Recall date
- December 19, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)