The product is a lyophilized growth supplement for use with… — Class II medical device recall Z-0801-2013
Terminated recall by Remel Inc, reported 2013-02-20, distributed in IL, IN, MI. The product may contain low level microbial contamination which could result in incorrect results.
| Recall number | Z-0801-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2012-10-10 |
| Classified | 2013-02-11 |
| Reported by FDA | 2013-02-20 |
| Terminated | 2013-06-04 |
| Distributed | IL, IN, MI |
| Quantity | 10 units |
| Reason classes | microbial contamination |
| Lot numbers | 1175209 |
Product
The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.
Reason for recall
The product may contain low level microbial contamination which could result in incorrect 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-0801-2013. 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.