Siemens Quinidine Assay Recalled for Precision Errors
Siemens is recalling 20 units of the Syva EMIT 2000 Quinidine Assay due to precision issues that may cause inaccurate test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source explicitly states the defect creates a risk of 'potential life-threatening cardiac arrhythmias,' which aligns with the rubric criterion for 'significant injury' reports or risks.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 20 units of the Syva EMIT 2000 Quinidine Assay (REF: 4Q019UL, Lot U1/UDI: 00842768001048). The affected units were distributed in California and Italy.
The recall is due to unacceptable precision performance in certain lots of the assay. This defect may lead to erroneously elevated quinidine measurements, which creates a risk of sub-optimal patient treatment. Such treatment errors could result in potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
Healthcare providers and facilities that have received this specific lot should stop using the product and contact Siemens Healthcare Diagnostics for instructions on return or disposal.
The recalled product
- Product
- Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot U1/UDI: 00842768001048
Distribution
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