Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determinati
Summary
The FDA issued a Class II for Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic us by Siemens Healthcare Diagnostics, Inc. Reason: 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 .
Details
Source
Device Recall
External ID
Z-2426-2021
Action Date
2021-09-15
Status
Ongoing
Category
device
Product Description
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 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236
Lot/Code Info: All lots impacted Kit lot numbers: 41331255 & 74682255 expiration date 2021-08-03, Lot number: 91605257 expiration date 2021-11-10.
Quantity Affected: 787 units
Reason for Recall
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
Distribution
Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-06
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 147 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-2426-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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