FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
- Recall number
- Z-2975-2026
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
- Status
- Open, Classified
- Initiated
- 2026-07-13
- Posted
- 2026-08-17
- Terminated
- not on file
- Reason
- 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.
- 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
- 20 units
- Distribution
- Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
- Lot, serial or model codes
- Lot U1/UDI: 00842768001048
- 510(k) numbers
- ["K922913"]
- PMA numbers
- not on file
- Product code
- LBZ
- Firm FEI
- 1219913
- Firm city
- East Walpole
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28