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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Lipase Flex Reagent Cartridge

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  Class 2 Device Recall Dimension Lipase Flex Reagent Cartridge see related information
Date Initiated by Firm December 14, 2017
Create Date May 10, 2018
Recall Status1 Terminated 3 on December 03, 2020
Recall Number Z-1796-2018
Recall Event ID 79468
Product Classification Lipase-esterase, enzymatic, photometric, lipase - Product Code CHI
Product Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
Code Information Catalog DF56 Lot FB8109- UDI# (01)00842768025532(10)FB8109(17)20180419
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
Po Box 6101
Newark DE 19702-2466
For Additional Information Contact Heydi Calderon
800-441-9250
Manufacturer Reason
for Recall		 Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-to-lot limits.
FDA Determined
Cause 2		 Under Investigation by firm
Action Customers are instructed to: - Discontinue use of Dimension LIPL Assay lot FB8109. ¿- Recalibrate with an alternate lot of Dimension LIPL Assay. ¿- Review their inventory of this lot to determine their laboratory¿fs no-charge replacement needs. ¿- Review the UMDR/UFSN letter with their Medical Director. ¿- Complete and return the Field Correction Effectiveness Check Form attached to the UMDR/UFSN letter within 30 days. - If they have received any complaints of illness or adverse events associated with lot FB8109, immediately contact their local Siemens Customer Care Center or their local Siemens Technical Support Representative
Distribution Domestic and Foreign consignees
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.
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