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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica IM Humidity Pack

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 Class 2 Device Recall Atellica IM Humidity Packsee related information
Date Initiated by FirmJanuary 06, 2020
Create DateMarch 04, 2020
Recall Status1 Terminated 3 on July 11, 2022
Recall NumberZ-1436-2020
Recall Event ID 84823
Product Classification unknown device name - Product Code N/A
ProductAtellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Humidity packs maintain reagent compartment humidity between 70100%. The operator loads 7 empty humidity packs initially.
Code Information Lot 0010
FEI Number 2432235
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information ContactGene Victori
862-219-4312
Manufacturer Reason
for Recall		A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
FDA Determined
Cause 2		Software in the Use Environment
ActionOn January 7, 2020, the firm issued an Urgent Medical Device Correction letter to all affected US customers. Customers were informed that the analyzer may erroneously identify that humidity packs Lot 0100 have expired and eject them. The firm is investigating the root cause and customers will be notified when additional information is available. The behavior will be corrected in a new version of software that will be available shortly. It is important to note that Humidity Packs do have an onboard stability (OBS) of 180 days that is monitored by the system software. Once loaded onto an analyzer, the OBS of each pack is monitored. The firm is not recommending a review of previously generated results, since the accuracy of results is not affected by this issue. Customers were given workaround instructions so that they may manually enter the humidity packs.
DistributionDomestic distribution nationwide. Foreign distribution worldwide.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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