Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents recall
Siemens Healthcare Diagnostics, Inc. recalled Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents on August 26, 2026 because of 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. It was sold nationwide.
Why it was recalled
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.
What's recalled
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Quantity: 20 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Siemens Healthcare Diagnostics, Inc., East Walpole, MA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Worldwide - US Nationwide distribution in the state of CA and the country of Italy. - Status
- Ongoing
- Recall number
- Z-2975-2026
- Source
- U.S. Food and Drug Administration
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