Elecsys BRAHMS PCT Immunoassay for the in vitro recall
Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA…
Why was Elecsys BRAHMS PCT Immunoassay for the in vitro recalled?
Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.
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?
Elecsys BRAHMS PCT: 07301715190 Lot number 204084
- Product
- Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA…
- Recalling firm
- Roche Diagnostics Corporation
- Quantity
- 47
- Distribution
- US Distribution in states of: CA, FL and IN.
- Recall date
- April 11, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)