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U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE /IMMULITE 1000 Systems COR

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  Class 2 Device Recall IMMULITE /IMMULITE 1000 Systems COR see related information
Date Initiated by Firm September 19, 2014
Date Posted October 23, 2014
Recall Status1 Terminated 3 on November 18, 2015
Recall Number Z-0122-2015
Recall Event ID 69321
510(K)Number K931409  
Product Classification Radioimmunoassay, cortisol - Product Code CGR
Product IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD.

For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.
Code Information Lots: 381 (exp. 10/31/2014), 382 (exp. 10/31/2014) and 383 (exp. 11/30/2014)
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics
511 Benedict Ave
Tarrytown NY 10591-5005
Manufacturer Reason
for Recall		 Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE 1000 on the Cortisol Assay reagent lots IMMULITE /IMMULITE 1000 (LKCO1) Lots 381,382 and 383 . Subsequently, the firm confirmed a positive bias on the IMMULITE/IMMULITE 1000 (LKCO1) Lots 381, 382 and 383.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action US Customers were sent an Urgent Medical Device Recall Letter (UMDR2014-09-19, dated 9/19/14) via FedEx on 9/19/14. Outside US Customers were sent an Urgent Field Safety Notice Letter. The letters inform the consignees of the recall of the IMMULITE/IMMULITE 1000 Cortisol (LKCO1) assay, kit lots 381, 382 and 383. Customers were asked to take the following actions: - Please review this letter with your Medical Director. - Discontinue use of and discard the IMMULITE/IMMULITE 1000 Cortisol kit lots listed in the letter. - Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. --- Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Field Safety Notice letter within thirty (30) days.
Quantity in Commerce US: 772 units, Canada: 43 units
Distribution Worldwide Distribution: US (nationwide) and internationally to Canada.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = CGR and Original Applicant = DIAGNOSTIC PRODUCTS CORP.
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