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U.S. Department of Health and Human Services

Class 2 Device Recall Syva EMIT 2000 Quinidine Assay

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 Class 2 Device Recall Syva EMIT 2000 Quinidine Assaysee related information
Date Initiated by FirmJuly 13, 2026
Date PostedAugust 17, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2975-2026
Recall Event ID 99446
510(K)NumberK922913 
Product Classification Enzyme immunoassay, quinidine - Product Code LBZ
ProductSyva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Code Information Lot U1/UDI: 00842768001048
FEI Number 1219913
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
333 Coney St
East Walpole MA 02032-1516
For Additional Information ContactLouise Mclaughlin
508-668-5000
Manufacturer Reason
for Recall		Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionOn July 14, 2026, Simens Healthineers issued a Urgent Medical Device Correction notification via FedEx. Simens asked consignees to take the following actions: 1. Review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 2. Discontinue use of and discard the kit lots listed in the Products Section. 3. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. 4. Retain this letter with your laboratory records and forward this letter to those who may have received this product.
Quantity in Commerce20 units
DistributionWorldwide - US Nationwide distribution in the state of CA and the country of Italy.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LBZ
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