Siemens Healthcare Recalls Emit 2000 Phenobarbital Assay Due to Imprecision
Siemens Healthcare Diagnostics is recalling specific lots of the Emit 2000 Phenobarbital Assay because they may produce imprecise results. The recall covers units distributed in the US and Mexico.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without explicit hospitalization reports or structural defects typically align with a High severity score, particularly when the hazard is a risk-of-harm product (imprecise diagnostic results) where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 4,963 units of the Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay. The recall is being conducted because certain lots of the product may exhibit imprecision. The affected lots are E5-E7, F1-F5, 1290, 1300, 1313, 1330, 1338, 1367, 1371, and 1380.
The recalled products were distributed nationwide in the United States and in Mexico. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Healthcare facilities and consumers should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions or a replacement. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 4,963
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 (10)
- Lots: E5-E7
- F1-F5
- 1290
- 1300
- 1313
- 1330
- 1338
- 1367
- 1371
- and 1380.
Distribution
Distributed nationwide across the United States.
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