Summary
The FDA issued a Class II for Atellica IM 1600 Analyzer, SMN 11066000 by Siemens Healthcare Diagnostics, Inc. Reason: 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 .
Details
Source
Device Recall
External ID
Z-0125-2022
Action Date
2021-10-27
Status
Ongoing
Category
device
Product Description
Atellica IM 1600 Analyzer, SMN 11066000
Lot/Code Info: All units.
Quantity Affected: 1733
Reason for Recall
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-28
Company
East Walpole, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics, Inc has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics, Inc have FDA actions?
Siemens Healthcare Diagnostics, Inc has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0125-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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