Atellica IM BR 27.29 recall
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29…
Why was Atellica IM BR 27.29 recalled?
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
All lots impacted Kit lot numbers: 41331255 & 74682255 expiration date 2021-08-03, Lot number: 91605257 expiration date 2021-11-10.
- Product
- Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- 787 units
- Distribution
- Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam
- Recall date
- September 15, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)