Siemens Emit Tox Serum Calibrators Recalled for Incorrect Expiration Date
Siemens Healthcare Diagnostics is recalling 1,998 cartons of Emit Tox Serum Calibrators because an incorrect expiration date was assigned to Lot D1.
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. The issue is a documentation error regarding the expiration date.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,998 cartons of Emit Tox Serum Calibrators, catalog number 7B019UL. The product is intended for use with the Emit Tox Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analysis of barbiturates and benzodiazepines in human serum.
The recall was initiated because an incorrect expiration date was assigned to Lot D1 of the calibrators. The correct expiration date is 2013-12-31, but the incorrect assigned expiration date is 2014-12-31.
The affected products were distributed nationwide to the following states: AL, AR, CA, CO, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NY, OH, PA, TN, TX, and WI. Users should stop using the affected calibrators and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 1,998
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 D1
Distribution
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