BD MAX PCR Cartridges Catalog #437519 — Class II medical device recall Z-0976-2013
Terminated recall by Becton Dickinson & Co., reported 2013-04-03, distributed in CA, FL, IL, IN, KS, NY, OH, OR…. Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or inva
| Recall number | Z-0976-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2012-12-11 |
| Classified | 2013-03-22 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2013-07-22 |
| Distributed | CA, FL, IL, IN, KS, NY, OH, OR, PA, TX, WI |
| Countries outside the US | BE |
| Lot numbers | 2235001 |
| Model numbers | 437519 |
Product
BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System.
Reason for recall
Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.
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-0976-2013. 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.