Siemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
Siemens Healthcare Diagnostics is recalling specific lots of the Emit 2000 Quinidine Assay because unacceptable precision may cause falsely high results, risking improper patient treatment.
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 recall is classified as FDA Class II and the source text explicitly cites a risk of 'life-threatening cardiac arrhythmias,' which aligns with the rubric criteria for Severe severity involving significant injury reports or high-risk medical device defects.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 55 units of the Beckman Coulter, Emit 2000 Quinidine Assay (REF: OSR4Q229). The affected lots are 2597, 2627, and 2709, with UDI 00842768023293. The product was distributed in California and Italy.
The recall was initiated due to unacceptable precision performance in certain lots. This defect may lead to erroneously elevated quinidine measurements. Inaccurate test results could result in sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
Healthcare facilities and laboratories that have received these specific lots should stop using the product and contact Siemens Healthcare Diagnostics for instructions on return or disposal.
The recalled product
- Product
- Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 55
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 (3)
- Lots: 2597
- 2627
- 2709/UDI: 00842768023293
Distribution
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