Alfa Wassermann System Diluent 750 mL Manufactured for Alfa… — Class II medical device recall Z-0743-2013
Terminated recall by Alfa Wassermann, Inc., reported 2013-02-06, distributed nationwide. Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
| Recall number | Z-0743-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alfa Wassermann, Inc., W Caldwell, NJ, United States |
| Recall initiated | 2012-10-10 |
| Classified | 2013-01-28 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2013-10-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, KY |
| Quantity | 4,104 kits |
| Lot numbers | 155599 |
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 for recall
Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0743-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.