FDA Device recall Z-0743-2013
Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 0700…
- FDA Device
- Class II
- terminated
- Published 2013-02-06
On 2013-02-06 the FDA classified a Class II recall of Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 0700… by Alfa Wassermann, citing inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0743-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-10 |
| Published | 2013-02-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alfa Wassermann |
| Distribution | US |
Product
Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.
Reason
Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
Identifiers
| code_info | Lot Number 155599 |
|---|
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-0743-2013%22
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