The Recall Desk
LowFDA (Devices)·Z-0665-2013·Announced 2013-01-16

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.

What this means for you

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 benzodiazepines
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

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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