FDA Device recall Z-0976-2013
BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 bo…
- FDA Device
- Class II
- terminated
- Published 2013-04-03
On 2013-04-03 the FDA classified a Class II recall of BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 bo… by Becton Dickinson And, citing cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0976-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-11 |
| Published | 2013-04-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Becton Dickinson And |
| Distribution | CA, FL, IL, IN, KS, NY, OH, OR, PA, TX, WI |
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
Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.
Identifiers
| code_info | Lot/Exp. date: 2235001 2014-08-22 |
|---|
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-0976-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.