Beckman Coulter Recalls Synchron Multi Calibrator Diskettes Due to Mislabeling
Beckman Coulter is recalling Synchron Multi Calibrator Diskettes because some units may be mislabeled as Thyroxine (T4) Reagent Calibrator Diskettes.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a labeling error rather than a direct physical hazard.
Plain-English summary
Beckman Coulter Inc. is recalling Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600, Lot M002642G. The recall was initiated because the manufacturer confirmed a mislabeling error where some of these diskettes may actually be Thyroxine (T4) Reagent Calibrator Diskettes.
The affected product is intended for use on Synchron Systems for the calibration of various analytes including Albumin, Blood Urea Nitrogen, Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate, Magnesium, Total Protein, Triglycerides, and Uric Acid. A total of 5,746 units were distributed worldwide, with 2,729 units distributed in the United States.
The agency has classified this recall as Class III. Users of these products should check their inventory for the specific part number and lot number listed above and contact Beckman Coulter for further instructions.
The recalled product
- Product
- Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
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 M002642
Distribution
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