FDA Device recall Z-0665-2013
Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(…
- FDA Device
- Class III
- terminated
- Published 2013-01-16
On 2013-01-16 the FDA classified a Class III recall of Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(… by Siemens Healthcare Diagnostics, citing incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The correct expiration date is 2013-12-31. The incorrect assigned expiration date is 201….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0665-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-12-06 |
| Published | 2013-01-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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 in human serum.
Reason
Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The correct expiration date is 2013-12-31. The incorrect assigned expiration date is 2014-12-31.
Identifiers
| code_info | Lot D1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0665-2013%22
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