Atellica IM 1300 Analyzer recall
Atellica IM 1300 Analyzer, SMN 11066001
Why was Atellica IM 1300 Analyzer recalled?
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
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 units
- Product
- Atellica IM 1300 Analyzer, SMN 11066001
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- 1193
- Distribution
- Domestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX UT VA WA WI WY. Foreign distribution worldwide.
- Recall date
- October 27, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)