Siemens Healthcare Recalls Phenobarbital Assay Kits Due to Imprecision
Siemens Healthcare Diagnostics is recalling specific lots of Emit 2000 and Syva Emit Phenobarbital Assays because they may show higher imprecision when used on Beckman Coulter AU Systems.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves higher imprecision in test results, which is a quality issue that could lead to incorrect clinical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 79,744 cartons of Emit 2000 Phenobarbital Assay (OSR4D229) and Syva Emit Phenobarbital Assay (4D019UL). The affected lots are 1151, 1167, 1191, and 1212 for the Emit 2000 assay, and D4, D5, D6, and D7 for the Syva Emit assay. These products are enzyme immunoassays used to measure phenobarbital levels.
The recall was initiated because the firm confirmed higher imprecision with the recalled lots when run on Beckman Coulter AU Systems. The source text notes that if the Syva Emit 2000 Phenobarbital Assay lots D4, D5, D6, and/or D7 are used as an application on AU Systems, the issue of higher within-run imprecision may be experienced. This imprecision is higher than what would normally be observed.
The affected products were distributed nationwide in the United States, specifically in the states of CA, FL, KS, MA, MN, MS, NM, NY, NC, OR, PA, TN, TX, UT, VA, and WA. Healthcare facilities and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 79,744
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 (9)
- Emit(R) 2000 Phenobarbital Assay (OSR4D229)
- lots 1151
- 1167
- 1191
- and/or 1212 and Syva(R) Emit(R) Phenobarbital Assay (4D019UL)
- lots D4
- D5
- D6
- and D7
Distribution
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · imprecision
See all →- HighAccess Total T4 thyroxine assay recalled for test imprecision
FDA (Devices) · 2024-03-27
- HighSiemens Magnesium Flex reagent cartridge recalled for imprecision and assay errors
FDA (Devices) · 2022-04-06
- HighDiagnostic thromboplastin reagent recalled due to performance issues
FDA (Devices) · 2021-12-01
- ModerateRandox Lipase Assay Substrate Recalled for Imprecision in Quality Control
FDA (Devices) · 2020-08-12
- ModerateRandox Lipase Assay Reagent Recalled for Imprecision in Quality Control and Patient Samples
FDA (Devices) · 2020-08-12