PREMIER EHEC and PREMIER EHEC Bulk — Class II medical device recall Z-1033-2017
Terminated recall by Meridian Bioscience Inc, reported 2017-01-25, distributed in AL, AZ, CA, CO, CT, FL, GA, IA…. Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with
| Recall number | Z-1033-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Meridian Bioscience Inc, Cincinnati, OH, United States |
| Recall initiated | 2016-11-08 |
| Classified | 2017-01-17 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2017-08-16 |
| Distributed | AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY |
| Countries outside the US | CA, DE, HK, IT, JP, NZ |
| Lot numbers | 608096H219, 608096H220, 608096H222, 608096H223, 608096H224, 608096H225, 608096H226, 608096H227, 8603.138, 8603.14, 8603.141, 8603.142, 8603.143 |
| Expiration dates | 2017-09-07, 2017-09-30, 2017-12-20, 2018-01-12, 2018-01-29, 2018-02-05, 2018-03-06, 2018-03-22 |
Product
PREMIER EHEC and PREMIER EHEC Bulk.
Reason for recall
Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
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-1033-2017. 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.