Z-2975-2026Class II

Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL

Name: Z-2975-2026 Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2026-07-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2026-07-13 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL on 2026-07-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2975-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-13
Posted: 2026-08-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Product code: LBZ Enzyme Immunoassay, Quinidine
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 root cause: Unknown/Undetermined by firm
Action: On 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 commerce: 20 units
Distribution: Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
Product codes and lots: Lot U1/UDI: 00842768001048

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2975-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2975-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-17
Z-2976-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-17

Product code LBZ

K922913Class IIEmit 2000 Quindine Assay Quididine CalibratorsSyva Co. / cleared 1992-08-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)