Z-0909-05

B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030...

Name: Z-0909-05 B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030...
Creator: Harmony Brands Llc
Published: 2005-03-25
License: https://open.fda.gov/license/

Harmony Brands LLC / initiated 2005-03-25 / Terminated

FDA source

Harmony Brands Llc began a recall of B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030 (case of 48 kits) and 28031 (case of 144 kits) on 2005-03-25. The reason FDA records is "Lack of assurance of safety and efficacy; products are from unknown sources". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0909-05
Status: Terminated
Initiated: 2005-03-25
Posted: 2005-06-21
Terminated: 2007-04-17
Recalling firm: Harmony Brands LLC
Product: B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030 (case of 48 kits) and 28031 (case of 144 kits).
Product code: LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Reason for recall: Lack of assurance of safety and efficacy; products are from unknown sources.
FDA root cause: Other
Action: Harmony issued a press release on 3/25/05. Consignees to the retail level were notified by letter beginning on 3/28/05.
Quantity in commerce: unknown.
Distribution: United States .
Product codes and lots: All lots.

Product code LCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)